Recommendationsof theEU-Japan Business Round Table
to the Leaders of the European Union and JapanTokyo, 8 & 9 April 2014

Working Party B
Life Sciences and Biotechnologies,
Healthcare and Well-being

Working Party Leaders:Prof. Dr. Wolfgang Plischke
Member of the Board ofManagement
Bayer AGMr. Osamu Nagayama
Chairman of the Board of Directors
President & CEO
Chugai Pharmaceutical Co., Ltd.

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List of Abbreviations
Abbreviation Meaning
ABS Access and Benefit Sharing
ARCB Association of Registered Certification
Bodies under PAL
CBD Convention on Biological Diversity
CE Conformite Europeenne
EFPIA European Federation of PharmaceuticalIndustries and Associations
EFSA European Food Safety Authority
EU European UnionFSC Food Safety Commission
GLP Good Laboratory Practice
GMP Good Manufacturing Practice
HTA Health Technology Assessment
IFAH International Federation of Animal Health
iPS induced Pluripotent Stem
J-PAL Japanese Pharmaceutical Affairs Law
JPMA The Japan Pharmaceutical Manufacturers
Association
LS & BT Life sciences and Biotechnologies
MAFF Ministry of Agriculture, Forestry and Fisheries
MDD Medical Device Directive
METI Ministry of Economy, Trade and Industry
MHLW Ministry of Health Labor and Welfare
MIC Ministry of Internal Affairs andCommunications
MNC Multinational Corporation
MOF Ministry of Finance
MRA Mutual Recognition Agreement
NB Notified Body
NHI National Health Insurance
PIC/S Pharmaceutical Inspection Convention andPharmaceutical Co-operation Scheme
PMDA Pharmaceutical and Medical Device Agency
QMS Quality Management System
VPD Vaccine Preventable Diseases
WP Working Party

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Introductory Statement
Both, Japan and the EU are facing numerous challenges due to e.g. an aging population,
shifting demands in just about all domestic markets and rising costs in many aspects of
the welfare system with a need to accelerate and focus on high-end innovations. Thisparticularly in the areas of Healthcare Plant Protection, and Biotechnology.
The enclosed recommendations of WP-B have the clear aim to improve the innovation
capabilities of both the EU and Japan through concrete action plans in life sciences andbiotechnology, which focus on measures to enhance efficient healthcare practices, foodtechnology / supply and biotechnology.

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Recommendations from both
European and Japanese industries
Healthcare
WP-B / # 01* / EJ to EJ Regulatory harmonization and MRA for pharmaceuticals
The regulatory harmonization and further extension of “Mutual Recognition Agreement”
should be proceeded in order to avoid redundant inspections of manufacturing facilities.
In addition to oral dosage forms, API, Sterile and Bio products are being requested toapply to the MRA. Full support is requested to expand the MRA of GMP to liquids, andsterile forms, API and bio products to avoid redundant inspections and testing<Recent Progress>
Some progress has been seen for this recommendation in that MHLW applied for
PIC/S in March 2012. PIC/S was applied in April 2012 and the practical inspection by
the global team has been completed. PMDA is expecting the approval in Q1/2014. As
the guideline enforces the harmonization of the inspections among PIC/S countries,
this issue might be settled in Q1/2014.
<Background>As currently only oral solid dosage forms are included within the MRA between Japanand the EU, there are still a lot of redundant inspections of manufacturing facilities.
This is not only a costly process, but it also slows down the launching of new drugs inJapan creating a significant disadvantage for Japanese patients.
In order to eliminate this problem and integrate EU-Japan economics more efficiently,
harmonization of standards / guidelines and expansion of MRA should be conductedunder mutual agreements. Below-mentioned are highly prioritized items forharmonization. Also, the MRA issue is one of items of the EPA negotiation between
EU and Japan.
<Other prioritized items for harmonization and MRA>
Harmonization:- Safety measures from surveillance to vigilance should be harmonized withinternational standards- Clinical development guideline and biological preparation standards for
Vaccine- Minimum Requirements for Biological Products

WP-B / # 02* / EJ to EJ Mutual recognition of quality management audit results for
medical devices between EU and Japan
Improve mutual recognition of Quality Management System (QMS) audit results forlower risk medical devices, e.g. those classified as Class II, ARCB under the JapanesePharmaceutical Affairs Law, as a first step.
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All industry-related manufacturers request PMDA and MHLW to further harmonize andstreamline the QMS audit results. MHLW has notified that RCBs can accept nonJapanese QMS audit results. However, ISO13485 continues to be only one part of theJapanese QMS ministerial ordinance. Hence, part of the Japanese requirements. To
resolve this issue, it is recommendable that QMS be evaluated on the basis of
ISO13485.
In addition to above, the recognition system of "Application for Accreditation of Foreign
Manufacturers” should be considered. Even if QMS is evaluated on ISO13485, allindustry-related manufacturers have to be registered and are obliged keeping theadditional Japanese requirements.
<Recent Progress>
Good progress has been seen for this recommendation. Improving QMS is included in
the J-PAL revision and the industry should work with the government to prepare
ordinance, which aligns with our recommendation. We recommend using ISO13485
audit report for QMS audit as an international standard as soon as possible.
<Background>
Based on Medical Devices Directive (MDD) of the EU and the JapanesePharmaceutical Affairs Law (J-PAL), QMS audit results are required for eachapplication for a license to introduce new medical devices in the market. In Europe
the regular annual ISO audit results can be used for all applications during the period
in which the ISO audit is valid. Recently, Japan has started to accept QMS audit
results at a specific manufacturing site for products with the same generic nameunder certain conditions. However, a number of RCBs still require submitting QMS
audit results for each application. Further alignment is necessary.

WP-B / # 03* / EJ to EJ Mutual recognition of medical devices product licenses
Introduce a mutual recognition of medical device product licenses between the EU andJapan. PMDA and MHLW should introduce a mutual recognition of medical device
product licenses with low risk of class II devices by taking the difference of classificationof medical devices between Japan and the EU into account. By harmonizing QMS andclassification it should be possible to introduce new products within the same time frame
and in one process. It is desirable that this issue will be solved quickly. Level difference
between NBs should also be considered. It should be recognized that the regulatory
approval scheme of class II medical devices in Japan is far from that in the EU, i.e. noneed to be reviewed by NBs for Conformite Europeenne (CE) marking of class II
medical device in the EU but reviewed by NBs in Japan.
<Recent Progress>
No progress / no dialogue has been seen for this recommendation. It is desirable thatJapan accepts the use of audit report ISO13485 (ISO14155 for clinical trials) issued
by the countries (USA, EU, Canada, Australia) with equal standards. To do so, JIS
standard should be eliminated from the QMS basic check list and thus rationalize thelicensing process.
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<Background>
Mutual recognition of licenses for medical devices in Japan and the EU would make itpossible to introduce new products in both the Japanese and European markets
within the same time frame and with one process.
As mentioned before, it could be possible to start with lower risk, class II devices.
The evaluation scheme between the Medical Devices Directive of the EU and theJapanese Pharmaceutical Affairs Law are quite similar, with- Evaluation schemes based on registered 3rd party bodies (Notified Bodies)- Essentially quite similar requirements- Based on ISO/IEC or JIS standard complianceWith these similarities, a mutual recognition should be easy to implement.

WP-B / # 04* / EJ to EJ Mutual recognition of clinical trial results for medical
devices
Introduce a mutual recognition of clinical trial results for medical device development.
Foreign clinical trial data have been accepted as a part of application dossier when; i)standards for conducting medical device clinical trials are set by the regulations of thecountry or region where the trial was performed, ii) the standards are equivalent or
surpass the Japanese medical device GCP, and iii) the clinical trial was conducted inaccordance with the standards or considered to have equivalent level of quality.
The GOJ encourages active use of consultation service on individual medical device
applications in advance provided by the Pharmaceuticals and Medical Devices Agency(PMDA) to address use of foreign clinical trial data for application of the device.
At present, clinical data are often accepted because the standards of clinical trials in the
United States or the EU are seen to be equivalent or sometimes more sophisticated thanthose required by the Japanese medical device GCP. However, then additional data are
required with unclear reasons.
In this regard, the ordinance was released in December 2012 by MHLW and some
improvements are expected. Further improvements are required in order to acceleratemutual recognition of clinical trial results for medical devices.
<Recent Progress>
Some progress has been seen in the area of mutual recognition of clinical trial results
but there is still a difference in Japan’s perception of mutual recognition.
<Background>
Differences in the definition of Good Clinical Practice between Japan and the EU
currently prevents the use of non-Japanese clinical trial results in the application for
new medical devices in Japan. Mutual recognition of clinical trial results would make itpossible to make new products available to patients in Japan and the EU within the
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same time frame and through one process, ensuring high level of quality while
reducing the burden on manufacturers.

Healthcare
WP-B / # 05** / EJ to E Evaluation of innovation values for pharmaceuticals inpricesThe EU government should reinforce its innovation policy to member states and clarify
its healthcare policy, resulting in the appropriate evaluation of the value ofpharmaceuticals.
<Recent Progress>
No progress has been seen for this recommendation. The Directorate-General for
Economic and Financial Affairs of the European Commission, ECFIN, issued a reporton drug cost containment methods of member states and recommended a "EU
reference price". As such, we would suggest to follow a reimbursement / pricing
system which clearly recognize innovation and innovative new products.
<Background>
In the EU, innovation policy is stated by the Lisbon declaration and the G10 groupreport indicating the importance of innovation in pharmaceuticals. However, eachstate operates its own healthcare system in different ways, resulting in gaps insurvival rates and the QOL of citizens. Under the current economic condition, pricesof pharmaceutical products are targeted as a major tool for medical cost containment.
BRT members call on the EU and Japan to clarify its healthcare policy and to discussand totally improve healthcare situations in member states by securing appropriate
healthcare budgets, preventing interference with patient access to new medicines andconsidering the proper utilization of healthcare technology assessment.

Plant Protection & Biotechnology
WP-B / # 06* / EJ to E Shortening review times of plant protection & biotechnology
products
Shorten review times for new applications/ registrations.
<Recent Progress>
Some progress has been seen for this recommendation.
<Background>Research and development of innovative and beneficial Plant Protection &Biotechnology products require high input costs. Therefore, timely access to themarkets is crucial for R&D-intensive companies in order to successfully market theirproducts and recover their initial R&D investments, which then again are used tofinance further innovations.
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Establishment and maintenance of science-based, predictable and timely regulatory
systems free from undue political influence and the appropriate protection of
proprietary data are therefore key requirements for sustainable and innovative
research.

Animal Health
WP-B / # 07* / EJ to E Introduction of “1-1-1 concept” for all animal healthproducts
Introduce 1-1-1 concept for all products (one dossier – one assessment – one decision
on marketing authorization applicable to all EU countries). A concept should be workedout between the respective governments / authorities.
<Recent Progress>
Some progress has been seen for this recommendation.
<Background>
One of the key objectives of the European Union is to create a single market forgoods. This goal has yet to be achieved for the animal health industry, with the
exception of centrally authorized products. In line with the concepts already existing in
the EU (i.e. quality, safety and efficacy described in one single EU dossier as thebasis for granting marketing authorizations for veterinary medicinal products, one
single assessment of the dossier employing the best expertise, resulting in one
decision for marketing authorization) the animal health industry in Europe is seeking asystemic change based on the one, one, one concept (“1-1-1 Concept”) for all
products. This appears to be the most simple and straightforward way to address allof the major shortcomings of the current system and to finally achieve the goal of asingle market for safe and efficacious veterinary medicines.

Healthcare
WP-B / # 08** / EJ to J Full-fledged implementation of the new drug pricing system
and abolishment of market expansion re-pricing
The premium for new drug creation and elimination of unapproved/off-label use drug will
be continued until March 2016. It is welcomed as it supports incentives for innovative
drug development; however, it is only the continuation of a trial scheme. The Japanese
government should finalize the implementation of the new, internationally competitive
drug pricing system in Japan based on the industry proposal since in addition to
innovation rewards it is also protecting public health. Furthermore, it adds an element ofpredictability and stability so that the industry can adequately plan, forecast productrequirements and effectively manage inventory as well as the distribution of productsWorking Party B, Life Sciences and Biotechnologies, Healthcare and Well-being
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across Japan.
The abolishment of the market expansion re-pricing was not accepted by the Central
Social Insurance Medical Council (Chuikyo) even though industries insisted to eliminate
the system. While the agenda for the 2014 NHI pricing discussion between Chuikyo andthe industry included topics such as “NHI pricing for long-listed products” and“continuation vs. discontinuation of incentives for innovative drug development” it did notinclude “abolishment of market expansion re-pricing”. Therefore, we urge to discuss this
topic to abolish the re-pricing rule by market expansion in the next pricing system reformin 2016, which is contrary to the policy of evaluating pharmaceutical innovation.
<Recent Progress>
No progress has been seen for this recommendation. The new drug pricing systemshould be implemented firmly and permanently (not only a 2-year trial).Furthermore,
the re-pricing system rule by market expansion can adversely affect innovation in
Japan and therefore, should be abolished.
<Background>
The NHI price reform proposed by the industry has been positively reviewed by
Chuikyo in December 2009 and the government decided to start a pilot
implementation in April 2010. This represented a significant improvement, as itprovides price stability for innovative drugs and was seen as a positive signal that theJapanese government is willing to reward innovation in the medical field. The
premium for new drugs will be continued until 2016. As a compensation for this new
scheme, the government will attach a system that fosters the registration of“unapproved/off-label use drugs”. Companies have received requests ondevelopments of many unapproved/off-label use drugs and forwarded those
constructively. Furthermore, companies received additional requests ondevelopments of another hundreds of unapproved/off label use drugs for several
times.
However, in the FY2014 drug pricing system reform, Chuikyo concluded to postpone
full-fledged implementation of the premium for new drug creation to FY2016 revision,even though the industry strongly requested. The conclusion brings the industry deep
concerns about sustainability for evaluation of innovations. The Japanese government
should implement the new premium system for innovative new drugs at the FY2016
drug pricing system revision to evaluate the companies’ efforts for elimination of theso-called drug lag in Japan and research and development of innovative new drugs.

WP-B / # 09** / EJ to J Appropriate assessment of innovative values of medical
devices in prices
Promote sub-dividing the current functional classification, enhance the premiums for C1
or C2 products (class-C products) and introduce a product-based listing system for new
products in order to move towards a product-based, market-oriented reimbursement
pricing system in the future.
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<Recent Progress>
Some progress and regress has been seen for this recommendation.
<Background>
Different from pharmaceutical brand-oriented pricing systems, about 300,000 medical
devices are classified into about 800 functional classes in Japan and one
reimbursement price is set for one functional class, based on structure, intended use,
effectiveness and so on.
Currently, various old and new products, having various realized prices, have thesame reimbursement price within one functional class, which means that the pricedrop of old products influences the reimbursement price of new ones on the revisionof the reimbursement price. This is the reason why the introduction of a productbased reimbursement pricing system is desired.
In Japan’s 2014 price revisions, the government’s efforts to progress forward theassessment of innovative values can be seen, such as making exception of functionalclass rule for the excellent and innovative class-C products to keep the independentfunctional class within the twice price revisions. On the other hand, they strengthened
the influence of foreign reference pricing.
We hope the Japanese government will make further efforts to promote medical
device development.

Plant Protection & Biotechnology
WP-B / # 10* / EJ to EJ Acceleration and dissemination of scientific knowledge on
GMOs by both the governments and the private sector
Governments and the private sector should speed up research in Plant Protection &Biotechnology and inform populations regularly and accurately about the state of play on
GMOs, based on sound scientific knowledge.
To that effect Japanese and European biotechnology and bio-industry associations
should work closely with other sectorial organisations and their respective Authorities.
<Recent Progress>
No progress has been seen for this recommendation.
<Background>A stable supply of food is an urgent requirement. While world population keeps
growing, the limits of enhancing conventional culture on existing farmlands are being
reached. GMOs offer the hope of breaking these limits, but remaining doubts about
their safety hamper the development of their utilisation. Considering this situation, it isan urgent matter to speed up research on GMOs and inform people regularly andaccurately about the state of play of that research.

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WP-B / # 11* / EJ to J Support research in Plant Protection & specifically
Biotechnology
Support research in Plant Protection & Biotechnology.
<Recent Progress>
No progress has been seen for this recommendation.
<Background>
Overall in Japan the cooperation between governmental institutes and MNC is limited.
Applied science is widely done for instance by PPS (Plant Protection Stations) in all
prefectures, however, this is not basic research. Also agricultural universities in Japando some research on an independent basis.
MAFF is spending around 400 Mio. Yen for residue trials on substances used for rice
to confirm the level of the residue in rice for feed and the transfer into livestock (cowand chicken) but the ownership is with the government or some independent institutes.
The project is motivated by the policy to increase food sufficiency rate. In the future,
MAFF should spend more money on basic research / fundamental technologies inorder to facilitate research activities in general. In biotechnology, considerable moneyis spent on plant molecular biological research but the budget is recently decreasing
and no GM products are developed in Japan. It should be taken into consideration todevelop GM rice in order to increase yield and decrease production costs. In the past,
the rice genome project was supported by the government but the project has been
finalized, a smaller post genome project is still running. The outcome of the project isonly contribution to develop a marker assisting the breeding of rice. From suchresearch where a considerable amount of Japanese tax payers’ money is invested,yielding practical applications is desirable through co-operations among governmental
institutes, universities, Japanese domestic companies and MNC.

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Recommendations from European industry
Animal Health
WP-B / # 12* / E to J Regulatory harmonization for animal health products
The food animal product registration process is particularly cumbersome, involving asequential review by MAFF followed by the FSC and the MHLW. Decision criteria andtimelines for the following stages of the review process are not provided, resulting in
extended review times and often different conclusions from regulators in other countries.
We propose to harmonize and streamline regulatory requirements for productregistration of animal health products. MAFF should start harmonization with related
countries as this is the path to the 1-1-1 concept recommended previously.
On Oct. 3rd 2013, J-MAFF already shared the idea at the explanatory meeting of revised
JPAL for the first time that J-MAFF, FSC and MHLW started discussion how to shorten
review times for livestock products (i.e. Introduction of parallel deliberation amongst theauthorities) but they didn’t show any timeline on the matter.
Clinical trials should be conducted at least at two sites and one of the trials should be
conducted in Japan.
<Recent Progress>
Some progress has been seen for this recommendation. In the notification, J-MAFF
made clear that marketing authorization will be granted with clinical trial data
conducted at least in two sites in foreign countries to confirm the reliability, on thecondition that the clinical trials were conducted according to overseas GCP. However,following clinical trials is not beneficial for new notifications. Clinical trials of
biologicals and clinical trials of new quinolones, in case the first-choice drug wasineffective.
<Background>
While such global new veterinary medicinal products go already through rigorous
review processes in Europe and the USA prior to registration, it requires substantial
additional testing in Japan under the Pharmaceutical Affairs Law before an approvalis granted. Restrictions on withdrawal period for innovative oil-adjuvant vaccines areespecially stringent in Japan. Increased harmonization of regulatory requirements
would certainly improve access of animals and animal owners to innovative animal
health products which are readily available in Europe.
An additional important aspect is the negative impact on animal welfare: since theregulatory requirements are not harmonized, the companies are required to repeat
some tests on animals in Japan, even though results of identical tests are alreadyavailable and are fully compliant with stringent frameworks like GLP or VICH.

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Recognition of animal welfare aspect is not yet optimal in the administration of animal
health products in Japan. Japan should minimize the use of animals by accepting
more overseas data and alternative approach.

WP-B / # 13* / E to EJ Mutual recognition of GMP and marketing authorization foranimal health products
With regard to the Mutual recognition of European and Japanese marketing
authorizations and recognition of GMP certification for veterinary products, MAFF should
work out harmonized regulations leading to the 1-1-1 concept.
The resources freed in MAFF could probably be diverted to speeding up the processingof dossiers in general, where MAFF has a severe lack of resources adding to the delay
in drug availability. However, no indication is found that MAFF is planning to makechanges.
<Recent Progress>
Some progress has been seen for this recommendation. However, further strong
efforts are required to reach mutual recognition of GMP.
<Background>
While laboratory testing is largely acceptable if conducted under GLP and according
to VICH standards, Japan still requires local clinical trials as there is no mutual
recognition of Good Manufacturing Practice (GMP) for veterinary medicinal products.
Moreover, any overseas production facilities that are involved in manufacturingveterinary medicinal products imported into Japan have to be accredited by MAFF
even though their GMP status is authorized by European authorities. This process
involves a large amount of administrative work. This research is obsolete as a newresearch was undertaken in 2012, which showed much improvement. An EU – Japan
Economic Integration Agreement should aim for mutual recognition of European andJapanese marketing authorization for veterinary products by starting off with mutual
recognition of GMP certification of veterinary medicines. Harmonized regulations on
animal vaccines should also be addressed under such an agreement.

WP-B / # 14* / E to EJ Responsible use of antibiotics in animal health
MAFF should promote responsible use of antibiotics in animal health.
Furthermore, the establishment of a cascading system, prioritizing the use of approved
drugs and formulations where they exist, rather than other available products lacking
such claims, would be a method promoting responsible use of all drugs in animal health.
<Recent Progress>
Some progress has been seen for this recommendation.
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In common with the rest of the world, Europeans and Japanese are concerned by thedevelopment of resistance to antibiotic medicines used in human health and thepotential threat that the use of antibiotics in animal health will accelerate this process.
The use of antibiotics as growth promoters has been prohibited in the EU since 2006.
As a responsible industry, the animal health industry seeks to work with veterinarians,
farmers and the feed industry to dispel the myths about the use of antibiotics inanimals and promote their responsible use.
In 2013, J-MAFF and Marketing Authorization Holders have shown activities. It can be
an option for J-MAFF to implement the consent from Marketing Authorization Holders
in order to facilitate prudent use of FQs (Floroquinalone). Although Marketing
Authorization Holders were able to define the addition of a precautionary statement in
the section of “dosage and administration”, such as, veterinaries should assess theefficacy of the drug within 3 days after the treatment started and the drug should bechanged in case of in-efficacy based on the veterinarian’s judgment. J-MAFF
released the general notification but no concrete plan was informed.

Healthcare
WP-B / # 15* / E to J Application of GMP on medicinal gases (manufacture of
medicinal gases) in Japan
Reinforce the regulation for GMP on medicinal gases in Japan. MHLW has started these
initiatives along with industries. But industries are protective to non-GMP facilities
because of financial implications.
<Recent Progress>
Some progress has been seen for this recommendation. In February 2012, MHLW
noticed to medical gas suppliers to obey voluntary standard by the industry. This
standard is almost compatible to GMP standard. PMDA / MHLW will reinforce the
GMP for medicinal gases through the PIC/S introduction in Japan in Q1/2014.
<Background>
Medicinal gases are drugs or medicinal devices and have to be compliant withgovernmental regulations. Main regulations are national Pharmacopeia, GMP (GoodManufacturing Practices), and GDP (Good Delivery Practices). Annex 6
describes GMP and GDP for medical gases: production and distribution. The currently
loose interpretation of GMP in Japan along with relatively low standards of JapanesePharmacopeia is of lower standards as compared to those applicable in Europe or the
US. We would like to suggest a reinforcement of regulations on GMP for medical
gases in Japan.

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WP-B / # 16* / E to J Requirement of Japanese version of the clinical trial protocol
and investigators brochure
The Japanese health authority requires a clinical trial protocol and investigator’s
brochure in Japanese. Translation from English is required for clinical trial notification in
Japan. The acceptance of English-only materials for global clinical trials performed inJapan requires further English language education of Japanese regulators. However, if
applications could be made in English-only, it would substantially accelerate the process
and make innovative drugs available to patients earlier in Japan.
MAFF, MHLW and FSC should start harmonized ways to shorten review times.
<Recent Progress>
No progress has been seen for this recommendation but currently, an English
application format is being positively discussed.
<Background>
The Japanese health authority requires a clinical trial protocol and investigator’s
brochure in Japanese. Translation from the original English version is required forclinical trial notification of global trials in Japan. Therefore, the requirement is
considered to be a cause for delay of the start for patients’ enrolment in Japan.

WP-B / # 17* / E to J Shorten or eliminate national tests for vaccines
For imported vaccines, national tests in both Japan and manufacturing sites have been
conducted (for more than 20 years in some cases). National tests for vaccines should be
eliminated or reduced to an absolute minimum.
<Recent Progress>
Some progress has been seen for this recommendation.
<Background>
Vaccine production is done according to GMP and PMDA periodical audits ofproduction sites. However, the higher quality assurance of vaccines is strongly
demanded by society. Concerning the national test results which are published by
MOU (memorandum of understanding), manufacturing countries should be acceptedby the Japanese authority and the national tests for vaccines in Japan should be
eliminated or reduced to an absolute minimum.

Animal Health
WP-B / # 18* / E to J Shortening review times for animal health products
Shorten review times for new product applications. MAFF, MHLW and FSC should start
harmonization to shorten review times. The process is complicated in addition to a
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review period that already for pet animal products (not requiring ADI and MRL) is among
the longest in the world. A lot of questions are asked in the process that might beacademically interesting but are not necessarily safety or efficacy related. Clarifying
registration requirements and shortening review times for importation of recombinantvaccines from Europe should also be implemented.
<Recent Progress>
No change or improvement was seen for this recommendation.
<Background>
In Japan, marketing authorization of a veterinary medicinal product is granted by the
Ministry of Agriculture, Forestry and Fisheries (MAFF). For an animal drug intended
for use in food-producing animals, the Food Safety Commission (FSC) and theMinistry of Health, Labour and Welfare (MHLW) are also involved in establishing theacceptable daily intake and maximum residue limit, respectively. The review process,involving three different authorities, is rather complex and certainly has some room for
efficiency improvement. Also, the review can take an extremely long time until
completion. Hence, it delays the access of animal owners and animals to innovative
animal health products. This is also true with the introduction of recombinant vaccinesfrom Europe due to lengthy processes of implementing the Cartagena protocol even if
the vaccine has already been extensively used in Europe.

WP-B / # 19* / E to J Japanese customs clearance’s (cc) rule for investigational
drugs and related materials does not allow efficient investigational drug supply
MAFF should harmonize with VICH guidelines.
<Recent Progress>
Some progress has been seen for this recommendation.
<Background>
To import investigational drugs either 1) the Original Clinical Trial Notification sealed
by both sponsor and PMDA or 2) YAKKAN is necessary. Recent clinical trials require
frequent investigational drug delivery from overseas investigational drug warehouseto study sites. Since both 1) and 2) should be archived by the sponsor and CC agents
do not keep those, frequent and timely CC is not possible. If a certified copy of 1) or
2) (certified by sponsor and kept by CC agent) is accepted by the custom,
investigational drug delivery will become efficient.

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Recommendations from Japanese industry
Healthcare
WP-B / # 20* / J to E Shorten the approval time to register new micro-organism
and introduce new technology for producing seasonings and amino acids
Shortening the approval time needed for registration of new materials and introduction of
new technologies which aim for product expansion, cost reduction, environmental
concerns or diversification of the fermentation material. Clarification of the approval
process is also requested.
<Recent Progress>
Some progress has been seen for this recommendation. Shortening the risk
assessment time by EFSA and clarification of the evaluation process are accelerated.
<Background>
The long term process for approving a set of safety evaluation such as the bacteria
manufacturing process, test products and co-products, delays the enhancement of
production and consequently, competitiveness in the EU market. The slow approval
process makes companies hesitate to invest in the EU market. On the other hand, italso weakens the export competitiveness of EU companies. For information: US
companies are introducing new technologies aggressively. In a typical case, one
application takes 30 month-long review time to complete approval processes byregulatory authority in EU, EFSA.

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