Notice of the General Office of the State Council on Issuing the Plan for the Pilot Program of the System of the Holders of Drug Marketing Licenses

• Document Number：No. 41 [2016] of the State Council
• Area of Law： Health and Sanitation
• Level of Authority： Regulatory Documents of the State Council
• Date issued：05-26-2016
• Effective Date：05-26-2016
• Status： Effective
• Issuing Authority： General Office of the State Council

Notice of the General Office of the State Council on Issuing the Plan for the Pilot Program of the System of the Holders of Drug Marketing Licenses
(No. 41 [2016] of the State Council)
The people's governments of all provinces, autonomous regions, and municipalities directly under the Central Government; all ministries and commissions of the State Council; and all institutions directly under the State Council:
The Plan for the Pilot Program of the System of the Holders of Drug Marketing Licenses, as approved by the State Council, is hereby issued:
The implementation of the pilot program of the system of the holders of drug marketing licenses is an important content of the reform of the drug review and approval system, and is of great significance to encouraging drug innovation and improving drug quality. All relevant regions shall attach great importance thereto, and, in accordance with the requirements of the pilot program, conscientiously organize the implementation thereof. The China Food and Drug Administration shall, jointly with the relevant departments, improve the supporting policies, strengthen organization and guidance, intensify supervision and inspection, and promote the pilot work in a reliable and orderly manner, so as to ensure the quality safety of the drugs of the varieties under the pilot program and the timely report of all major information and problems to the State Council.
General Office of the State Council
May 26, 2016
Plan for the Pilot Program of the System of the Holders of Drug Marketing Licenses
In accordance with the Decision of the Standing Committee of the National People's Congress on Authorizing the State Council to Conduct the Pilot Program of the System of the Holders of Drug Marketing Licenses in Certain Areas and the Relevant Issues, the pilot program of the system of the holders of drug marketing licenses is to be conducted in ten provinces (cities), namely, Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan. The following plan is hereby made for effectively conducting the pilot work.
I. Contents of the Pilot Program
The drug research and development (“R&D”) institutions and scientific research personnel within pilot administrative regions may file drug clinical trial applications and drug marketing applications as drug registration applicants (hereinafter referred to as “applicants”), and the applicants that obtain drug marketing licenses and drug approval numbers are eligible as the holders of drug marketing licenses (hereinafter referred to as “holders”). The relevant legal liabilities for drug clinical trials and drug production and marketing as prescribed in laws and regulations shall be undertaken by the applicants and holders.
A holder that does not possess the corresponding production qualification shall entrust a qualified drug production enterprise (hereinafter referred to as an “entrusted production enterprise”) within the pilot administrative region to produce the drugs approved to be marketed. Where a holder possesses the corresponding production qualification, it may conduct production by itself or authorize an entrusted production enterprise to conduct production.
During the period of review and approval or after approval of a drug registration application, an applicant or holder may file a supplementary application for the modification of the applicant, holder or entrusted production enterprise.
II. Scope of Pilot Drugs
(1) New drugs approved to be marketed after the implementation of this Plan, including: (a) chemical drugs of Class I through Class IV and Class V (only limited to targeting preparations, sustained release preparations, and controlled release preparations) declared according to the registration classification in the current Measures for the Administration of Drug Registration, traditional Chinese medicines and natural medicines of Class I through Class VI, biological products for curative uses of Class I and Class VII and biosimilars; and (b) the chemical drugs of Class I and Class II declared according to the new chemical drug registration classification (hereinafter referred to as “new registration classification”) after the reform of the chemical drug registration classification.
(2) Generic drugs approved to be marketed according to the new standards consistent with those for the quality and efficacy of reference listed drugs, including chemical drugs of Class III and Class IV declared according to the new chemical drug registration classification after the reform of the chemical drug registration classification.
(3) Certain drugs that have been approved to be marketed before the implementation of this Plan, including: (a) drugs that have passed the quality and efficacy consistency evaluation; and (b) the drugs whose drug approval numbers are held by the drug production enterprises which are relocated in their entirety or are relocated in their entirety after they are merged within the pilot administrative regions.
Narcotic drugs, psychotropic substances, toxic drugs for medical treatment, radioactive drugs, preventive biological products and blood products are not included in the scope of pilot drugs.
III. Conditions for Applicants and Holders
To be eligible as applicants and holders, drug R&D institutions or scientific research personnel shall meet the following conditions:
(1) Basic conditions.
(a) They fall within the scope of the drug R&D institutions that are legally formed within the pilot administrative regions and are capable of assuming liabilities independently, or the scientific research personnel who work within the pilot administrative regions and are of the nationality of the People's Republic of China.
(b) They are capable of assuming liabilities for the quality safety of drugs.
(2) Application materials:
(a) Qualification certification documents.
(i) Photocopies of the legal registration certification documents (business licenses, among others) which shall be submitted by the drug R&D institutions.
(ii) Photocopies of resident identity cards, personal credit reports, job resumes (including education background, work experience on drug R&D and other information) and letters of commitment on honesty and trustworthiness, which shall be submitted by scientific research personnel.
(b) Relevant documents on the capabilities of assuming liabilities for drug quality safety.
(i) Where scientific research personnel apply for the clinical trials of drugs, they shall submit to the provincial drug supervision and administration departments at the places where they are located the letters of commitment to assuming the risk liabilities for the clinical trials of drugs, promising that they will submit to the provincial drug supervision and administration departments at the places where they are located the guarantee agreements concluded with the guarantors or the insurance contracts concluded with the insurance agencies before the implementation of the clinical trials.
(ii) Where drug R&D institutions or scientific research personnel apply for being eligible holders, they shall submit the letters of commitment to assuming the liabilities for drug quality safety, promising that they will submit to the provincial drug supervision and administration departments at the places where they are located the guarantee agreements concluded with the guarantors or the insurance contracts concluded with the insurance agencies before the drugs are marketed, and that they will submit the insurance contracts on injection drugs before such drugs are marketed.
IV. Conditions for Entrusted Production Enterprises
An entrusted production enterprise is a drug production enterprise which is legally formed within a pilot administrative region and holds the Dug Production License and the Good Manufacture Practice (GMP) authentication certificate within the corresponding drug production scope.
V. Obligations and Responsibilities of the Applicants and Holders
(1) Applicants and holders shall perform the corresponding obligations of drug registration applicants and drug production enterprises in terms of drug R&D registration, production, circulation, monitoring and evaluation, among others, as prescribed in the Drug Administration Law of the People's Republic of China (hereinafter referred to as the “Drug Administration Law”) and other relevant laws and regulations, and assume the corresponding legal liabilities.
(2) Holders shall conclude written contracts and quality agreements with the entrusted production enterprises to stipulate the rights, obligations and responsibilities of both parties.
(3) Holders shall entrust the entrusted production enterprises or the qualified drug trading enterprises to sell drugs on their behalves, agree on the relevant sale requirements, supervise and urge their compliance with the relevant laws and regulations, and perform the drug traceability management responsibilities.
(4) Holders shall take the initiative to disclose via the Internet the drug marketing licensing approval information, drug instructions, and rational drug use information, among others, to facilitate social inquiry.
(5) Where the drugs approved to be marketed have caused any personal injuries, the victims may claim for compensation from holders or the entrusted production enterprises or sellers, among others. If the entrusted production enterprises or sellers are held liable for such personal injuries and the holders make the compensation, the holders are entitled to claim compensation from the entrusted production enterprises or sellers. If the holders are held liable for such personal injuries and the entrusted production enterprises or sellers make the compensation, the entrusted production enterprises are entitled to claim compensation from the holders. The specific issues shall be governed by the Tort Law of the People's Republic of China and other relevant provisions.
VI. Obligations and Responsibilities of Entrusted Production Enterprises
(1) They shall perform the obligations of the relevant drug production enterprises in terms of drug production as prescribed in the Drug Administration Law and other laws and regulations, and assume the corresponding legal liabilities.
(2) They shall perform the relevant obligations as agreed on with holders in accordance with the law, and assume the corresponding legal liabilities.
VII. Applications of Holders
(1) Newly registered drugs.
Where the drugs newly registered after the implementation of this Plan meet the requirements of the pilot program, the applicant may apply for being eligible as holders while submitting the applications for the clinical trials of drugs or for making the drugs.
Where any clinical trial application has been accepted before the implementation of this Plan, but the drugs have not been approved to be marketed, if the application meets the requirements of the pilot program, the applicant may file a supplementary application for being eligible as a holder.
An applicant that is to entrust an entrusted company to produce drugs shall submit the information on the entrusted production enterprise while filing the application or supplementary application for drug marketing.
(2) Drugs that have been approved to be marketed
Where the drugs that have been approved to be marketed before the implementation of this Plan comply with the requirements of the pilot program, the applicant may file a supplementary application for being eligible as a holder.
An applicant that is to entrust an entrusted production enterprise to produce drugs shall submit the information on the entrusted production enterprise while submitting a supplementary application.
(3) Modification application.
Where a holder's drug marketing application is approved, it may file a supplementary application for the modification of the holder or the entrusted production enterprise. During the period when a drug clinical trial application or drug marketing application has been accepted but not yet been approved, the applicant may file a supplementary application for the modification of the applicant or the entrusted production enterprise.
Where a holder or applicant is modified, the transferor and the transferee shall jointly file an application with the provincial drug supervision and administration department at the place where the transferee is located, and the provincial drug supervision and administration department shall submit the application to the China Food and Drug Administration for approval. Where the entrusted production enterprise is to be modified, the holder or applicant shall file an application with the provincial drug supervision and administration department at the place where it is located, and the provincial drug supervision and administration department shall submit the application to the China Food and Drug Administration for approval.
(4) Other requirements
The approval certification documents for the drugs of the varieties under the pilot program shall specify the relevant information on the holders and the entrusted production enterprises, among others, and state that the holders should, in accordance with the relevant requirements, submit to the provincial drug supervision and administration departments at the places where they are located the guarantee agreements concluded with the guarantors or the insurance contracts concluded with the insurance agencies.
The instructions on the drugs of the varieties under the pilot program and packaging labels shall specify the information on holders and production enterprises, among others.
The drug approval numbers approved and issued during the implementation of the pilot program shall continue to be valid during the valid period specified in the drug registration approval documents after the pilot program expires.
VIII. Supervision and Administration
(1) Supervision and administration of drugs after they are marketed.
The provincial drug supervision and administration departments at the places where holders are located shall take charge of supervising and administering the holders and the drugs approved to be marketed, and join hands with the provincial drug supervision and administration departments at the places where the entrusted production enterprises are located to extend the network of supervision and administration; and shall strengthen the supervision and administration of holders' performance of the obligations of guaranteeing drug quality, marketing sale and services, drug monitoring and evaluation and drug recall, among others, and supervise and urge holders' establishment of strict quality administration system, so as to ensure the effective performance of responsibilities.
The provincial drug supervision and administration departments at the places where production enterprises are located shall strengthen the supervision and inspection of the production by drug manufacturers under the condition of drug GMP. When any risks in the process of production or operation are found, they shall take control measures in a timely manner.
Where drug supervision and administration departments find any quality risks in the drugs to be marketed, they shall, in light of the actual circumstances, take such risk control measures as interview of the holders and relevant entities, issuance of warning letters, rectification within a prescribed time limit, revision of drug instructions, restricted use, supervision of recalled drugs, revocation of drug approval certification documents, and suspension of development, production, sale, and use of such drugs, among others.
Where any holders or entrusted production enterprises violate the Drug Administration Law or other laws or regulations or the relevant provisions of this Plan, the provincial drug supervision and administration departments at the places where the holders are located shall investigate and punish them in accordance with the law, and relevant persons shall be held liable.
(2) Information disclosure.
The China Food and Drug Administration shall, under the relevant provisions, take the initiative to disclose the relevant information on the acceptance, review, approval and modification after marketing of the drugs of the varieties under the pilot program, among others.
Provincial drug supervision and administration departments shall take the initiative to disclose the relevant supervision and administration information on holders' performance of obligations, routine supervision and inspection and administrative penalty, among others.
IX. Others
This Plan shall come into force on the date of issuance, and shall be implemented until November 4, 2018. The relevant provisions on holders in this Plan shall apply, mutatis mutandis, to the drug production enterprises within the pilot administrative regions.
The power to interpret this Plan shall remain with the China Food and Drug Administration.