General Office of the State Council, Plan for a Pilot Project for the Marketing Authorization Holder System for Pharmaceuticals

Scope of pilot pharmaceuticals:

(1) New pharmaceuticals for which marketing approval has been secured after the implementation of this Plan.

(2) Generic drugs for which marketing approval has been secured based on the new standard for quality and effectiveness that is identical to that for the innovator pharmaceutical product.

(3) Certain pharmaceuticals for which marketing approval was secured before the implementation of this Plan (Article 2).

Conditions that a pharmaceutical research and development institution or researcher is required to satisfy to become an Applicant or MAH:

(1) being a pharmaceutical research and development institution that is lawfully established in a pilot administrative region and that can independently bear liability, or a researcher working in a pilot administrative region and holding Chinese nationality; and

(2) having the capacity to bear liability for pharmaceutical quality and safety (Article 3).

A Commissioned Enterprise shall be a pharmaceutical production enterprise that is lawfully established in a pilot administrative region and that has a Pharmaceutical Production Permit for the appropriate pharmaceutical production scope and a pharmaceutical good management practice (GMP) certificate (Article 4).

If a pharmaceutical for which marketing approval has been secured causes personal injury, the victim may seek compensation from the MAH or, alternatively, from the Commissioned Enterprise, the seller, etc. If the liability falls on the Commissioned Enterprise or the seller, but it is the MAH that pays compensation, the MAH shall have the right to recover the same from the Commissioned Enterprise or the seller. If the liability falls on the MAH, but it is the Commissioned Enterprise or the seller that pays compensation, the Commissioned Enterprise or the seller shall have the right to recover the same from the MAH. The specifics thereof shall be handled in accordance with the PRC Tort Liability Law, etc (Article 5).

The provisions of this Plan concerning Holders shall apply mutatis mutandis to pharmaceutical production enterprises in pilot administrative regions (Article 9).

Related legislation: Decision on Authorizing the State Council to Launch a Pilot Project for the Marketing Authorization Holder System in Certain Regions and Relevant Issues Thereof; and PRC Law on the Administration of Pharmaceuticals (2nd Revision)

Issued: May 26 2016

Effective: May 26 2016 to November 4 2018

Main contents: A pharmaceutical research and development institution or researcher in a pilot administrative region may, as a pharmaceutical registration applicant (an Applicant), submit a pharmaceutical clinical trial application or pharmaceutical marketing application. If the Applicant secures marketing authorization and a pharmaceutical approval document number, it/he/she may become a marketing authorization holder (an MAH). The legal liability relating to pharmaceutical clinical trials and pharmaceutical production and marketing specified in laws and regulations shall be borne by the Applicant or MAH as appropriate.

An MAH that does not have the appropriate production qualifications must engage a qualified pharmaceutical production enterprise in a pilot administrative region (the Commissioned Enterprise) to produce the pharmaceutical for which marketing approval has been secured. If the MAH has the appropriate production qualifications, it/he/she may do the production itself/himself/herself or, alternatively, engage a Commissioned Enterprise to do so (Article 1).

Scope of pilot pharmaceuticals:

(1) New pharmaceuticals for which marketing approval has been secured after the implementation of this Plan.

(2) Generic drugs for which marketing approval has been secured based on the new standard for quality and effectiveness that is identical to that for the innovator pharmaceutical product.

(3) Certain pharmaceuticals for which marketing approval was secured before the implementation of this Plan (Article 2).

Conditions that a pharmaceutical research and development institution or researcher is required to satisfy to become an Applicant or MAH:

(1) being a pharmaceutical research and development institution that is lawfully established in a pilot administrative region and that can independently bear liability, or a researcher working in a pilot administrative region and holding Chinese nationality; and

(2) having the capacity to bear liability for pharmaceutical quality and safety (Article 3).

A Commissioned Enterprise shall be a pharmaceutical production enterprise that is lawfully established in a pilot administrative region and that has a Pharmaceutical Production Permit for the appropriate pharmaceutical production scope and a pharmaceutical good management practice (GMP) certificate (Article 4).

If a pharmaceutical for which marketing approval has been secured causes personal injury, the victim may seek compensation from the MAH or, alternatively, from the Commissioned Enterprise, the seller, etc. If the liability falls on the Commissioned Enterprise or the seller, but it is the MAH that pays compensation, the MAH shall have the right to recover the same from the Commissioned Enterprise or the seller. If the liability falls on the MAH, but it is the Commissioned Enterprise or the seller that pays compensation, the Commissioned Enterprise or the seller shall have the right to recover the same from the MAH. The specifics thereof shall be handled in accordance with the PRC Tort Liability Law, etc (Article 5).

The provisions of this Plan concerning Holders shall apply mutatis mutandis to pharmaceutical production enterprises in pilot administrative regions (Article 9).

Related legislation: Decision on Authorizing the State Council to Launch a Pilot Project for the Marketing Authorization Holder System in Certain Regions and Relevant Issues Thereof; and PRC Law on the Administration of Pharmaceuticals (2nd Revision)