Review Efficiency and Timeline Predictability of Pre-Review andOnline Registration Systems in Asian countries〇Yuto Kurooka1, Masaaki Kannno1, Kunihiko Kiyono1, Yukio Washio1, Yoshiaki Ito1, Junichi Nishino1
1 Otsuka Pharmaceutical Co., Ltd. Regulatory Affairs Department

BackgroundPurpose In Asian countries, there is an increasing trend of countries
implementing the systems of pre-review and online registrationfor Health Authority(HA)’s review process of drug application.

From the perspective of early access topatients, in Asian countries, we made asurvey on the role and actual operationof pre-review and online registration
system, and considered from the view
point of review efficiency, transparency
and predictability.

 In some countries, HAs request the applicants to complete online
registrations of administrative and CMC data on API, excipients,
and packaging materials, which are needed in advance to get thementioned pre-review initiated.

Challenges

 These situations has the potential to complicate the review
process and cause delays in the review timeline for drug approval.

Efficiency

Method Survey Methods
Using Microsoft Forms, questionnaires were distributed to thesubsidiaries of Otsuka in 13 Asian countries in Q4 2022.
 Main Topics of SurveyCountry
China
Hong KongIndonesia
India
South Korea
MyanmarMalaysia

白抜き- The role of pre-review stage and whether it is conducted prior
to a full-scale NDA review- The timeline and process of the review from NDA submission
to acceptance- Online registration system

Results
Definition of the terms

Pre-review: To conduct a screening review before entering NDA full scale
review stage, and in some countries, verification takes place
before screening.
Screening: to evaluate qualification for entry to NDA stage, andTransparency

Alpha-2
code
CNHKIDINKRMMMYCountry
Philippines
Singapore
ThailandTurkeyTaiwanVietnam

Predictability

Alpha-2
code
PHSG
TH
TRTW
VN

Total: 13 countries

determine appropriate review path.
Verification: To check completeness and assess acceptability of application
dossiers. If the application has passed Verification, it means theapplication gets official acceptance by HA.
Official acceptance: To accept the application for HA’s review (Not just receiving theapplication dossiers from applicants).

1. Pre-review and Verification
1-2. Things to be determined during pre-review step

1-1. The existence and role of pre-review

CountrySGID

Role of Pre-review (Examples)
To ensure the correctness of the application type and the completenessof the dossier for review.
As pre-screening of registration including to determine registration
category, review pathway, review fee and registration document.

1-3. The period of pre-review stepWorking Days

• 8 countries have implemented a pre-review system, 9 countries
conduct a formal verification before officially accepting the application,and 3 countries immediately acknowledge official acceptance at thetime of submission and proceed directly to full scale NDA review.
• The role of Pre-review is not only to check the completeness ofapplication dossiers but also to determine appropriate review path ordesignate special review track.

2. Online Registration System
2-1. Method of filing application dossiers

2-2. Number of days to enter application informationin registration system online based on the experience

2-3. Whether or not applicants can check HA’s review progress
HA Review Process
Time-clock
Review Milestone

MethodHA’s website
Online Registration System
HA’s website
None of the above can be confirmed

Conclusion

CountryID
HK, MM, MY, SG
CN, KR, PH
IN, TH, TR, TW, VN•

10 countries implement the online
registration system or eCTD, however, somecountries faced challenges such as theapplicant requiring a significant amount oftime for inputting the information into thesystem.

Pre-review system not only confirms the completeness of submitted dossiers, but also serves as crucial step to decide thereview path in the subsequent NDA stage, which helps applicants to adapt to the deficiencies and/or designated path inearly stage, improving the review efficiency and timeline predictability. Furthermore, online registration systems could
facilitate applicants to track the progress of review milestones, while contributing to the transparency of review processes.