Title: Act on Partial Revision of the Employees' Pension Insurance Act, etc. for Securing the Soundness and Reliability of Public Pension Insurance Systems
Promulgation Date: June 26, 2013
Effective Date: April 1, 2014
Act No.: 63	Responsible Division: Corporate Pension and National Pension Fund Division, Pension Bureau
1. Purpose of the lawIn order to secure soundness and reliability of the public pension system, necessary measures shall be taken to [1] introduce an exceptional dissolution system for Employees' Pension Funds while promoting their transfer to other corporate pension systems and [2] enable payment of insurance premiums for the conflicting period of pension records of Category-3 insured persons of National Pension, etc.2. Outline of the law(1) Revision of the Employees' Pension Fund system[1] Establishment of a new Employees' Pension Fund shall be disallowed after the enforcement date.[2] The exceptional dissolution system shall be revised as a 5-year provisional measure from the enforcement date and exceptions for the deadline for payment and payment methods of minimum reserves to be paid to the government at the time of dissolution of the Fund, including removing the joint obligation between business offices for payments under an installment plan, etc., shall be established.[3] The Minister of Health, Labour and Welfare shall be able to issue a dissolution order for Funds that do not meet the standards set from the point of view of securing the safety of managed assets after hearing the opinions from a third-party panel.[4] In order to support the securing of the right to receive extra payments, exceptions shall be established for transferring reserve funds from Employees' Pension Funds to other corporation pension systems, etc.(2) Response to issues of conflicting records of Category-3 insured persons (*)In order to respond in accordance with the social security principles of benefits being paid according to the actual payments of insurance premiums, the following measures shall be taken:[1] Correcting the pension amounts based on the conflicting records to the correct amounts with certain consideration paid to the stability of lives of pension recipients.[2] Preventing the situation of pension not being received by treating the conflicting period as an “empty period” (not reflected to the pension amounts, but included in the period required for receiving pension benefits)[3] Allowing additional exceptional payments for the conflicting period in the past 10 years in order to provide opportunities to recover pension amounts (3-year provisional measure)(*) The issue of Category-3 insured persons who are dependent spouses (full-time housewives, etc.) of salaried workers (Category-2 insured persons) actually becoming Category-1 insured persons due to the Category-2 insured persons leaving their jobs, but remaining as Category-3 insured persons on their pension records, thus causing conflicts.(3) OthersThe periods of the special measures on the payment requirements for disability/survivors' pension and the system for granting grace period for the payment of National Pension premiums for young people shall be extended ten years.3. Effective date(1) shall come into effect on April 1, 2014(2) shall come into effect on July 1, 2013 ([3] on April 1, 2015 and [2] on April 1, 2018)(3) shall come into effect on the promulgation date (June 26, 2013)

Title: Act on Partial Revision of the Pharmaceutical Affairs Act, etc.
Promulgation Date: November 27, 2013	Effective Date: Scheduled to be late November 2014
Act No.: 84	Responsible Division: General Affairs Division, Pharmaceutical and Food Safety Bureau
<Purpose>In order to safely and promptly provide innovative drugs and medical devices, etc. to the people, obligation to submit product documents of drugs and medical devices, etc. shall be created, the scope of certification of medical devices by accredited certification bodies shall be expanded, and conditional/temporary certification system for regenerative medicine products shall be created.
<Outline>1. Strengthening of safety measures for drugs and medical devices, etc. (1) Implementation of necessary regulations to prevent occurrence/expansion of health risks shall be clearly stated as the purpose of the Partial Revision of the Pharmaceutical Affairs Act. (2) Relevant parties shall be obligated to secure quality, efficacy, and safety of drugs, etc. (3) Manufacturers and marketers of drugs, etc. shall create product documents based on the latest knowledge and submit them to the Minister of Health, Labour and Welfare. 2. Establishment of regulations that take into consideration the characteristics of medical devices, etc. (1) Regulations for marketing/manufacturing of medical devices shall be provided in a chapter different from that of drugs, etc. (2) The certification system of private third-party institutions for medical devices shall be expanded to specially controlled medical devices with the standards being set. (3) Stand-alone programs used for diagnosis shall be subject to approval/certification for marketing as medical devices. (4) The system used for manufacturing of medical devices shall be simplified, from the approval system to the registration system. (5) Examination of conformity to the standards of manufacturing/quality management methods of medical devices shall be streamed. 3. Establishment of regulations that take into consideration the characteristics of regenerative medicine products, etc. (1) “Regenerative products, etc.” shall be newly defined and regulations on safety measures, etc. that take into consideration their characteristics shall be established. (2) Heterogeneous regenerative medicine products, etc. which are assumed to be effective may specially and promptly be granted approval for marketing under certain conditions and period of time if their safety is confirmed. 4. Title The title of the Pharmaceutical Affairs Act shall be revised to the “Act on Securing Quality, Efficacy, and Safety of Pharmaceuticals and Medical Devices, etc.”. <Effective Date> Scheduled to be late November 2014