According to the "Decision of the Standing Committee of the National People's Congress on Authorizing the State Council to Carry out Pilot Programs of Drug Marketing Authorization Holder System in Some Places and Related Issues", the drug marketing authorization holder system pilot program is being carried out in 10 provinces (municipalities) including Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan. The following plan is now formulated to do a good job in the pilot work.
I. Pilot Content
Drug research and development institutions or scientific researchers in the pilot administrative area can act as drug registration applicants (hereinafter referred to as applicants) to submit drug clinical trial applications and drug marketing applications. If the applicant obtains drug marketing authorization and drug approval number, he can become a drug marketing authorization holder (hereinafter referred to as the holder). The legal responsibilities related to drug clinical trials and drug production and marketing prescribed by laws and regulations shall be borne by the applicant and the holder accordingly.
If the holder does not have the corresponding production qualifications, it must entrust a qualified drug manufacturer (hereinafter referred to as the entrusted manufacturer) in the pilot administrative area to produce the approved drugs. If the holder has the corresponding production qualifications, it can produce by itself or entrust the entrusted manufacturer to produce.
During the review and approval period of drug registration applications or after approval, the applicant or holder may submit a supplementary application to change the applicant, holder or entrusted production enterprise.
II. Scope of pilot drugs
(I) New drugs approved for marketing after the implementation of this plan. Specifically include: 1. Chemical drugs of categories 1-4 and 5 (only targeted preparations, sustained-release preparations, and controlled-release preparations), traditional Chinese medicines and natural medicines of categories 1-6, therapeutic biological products of categories 1 and 7, and biosimilars declared in accordance with the registration classification of the current "Drug Registration Management Measures"; 2. Chemical drugs of categories 1-2 declared in accordance with the new chemical drug registration classification (hereinafter referred to as the new registration classification) after the implementation of the chemical drug registration classification reform.
(II) Generic drugs approved for marketing according to new standards consistent with the quality and efficacy of original research drugs. Specifically include: Chemical drugs of categories 3-4 declared in accordance with the new registration classification after the implementation of the chemical drug registration classification reform.
(III) Some drugs approved for marketing before the implementation of this plan. Specifically include: 1. Drugs that have passed the quality and efficacy consistency evaluation; 2. Drugs that have drug approval numbers held by drug manufacturers that have relocated as a whole or merged and relocated as a whole within the pilot administrative region.
Anesthetic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, preventive biological products, and blood products are not included in the scope of pilot drugs.
III. Applicant and holder conditions
Conditions for drug research and development institutions or scientific researchers to become applicants and holders:
(I) Basic conditions.
1. Drug research and development institutions that are legally established in the pilot administrative region and can assume independent responsibility, or scientific researchers who work in the pilot administrative region and have the nationality of the People's Republic of China.
2. Have the ability to assume responsibility for drug quality and safety.
(II) Application materials.
1. Qualification certification documents.
(1) Drug research and development institutions shall submit copies of legal registration certification documents (such as business licenses).
(2) Scientific researchers shall submit copies of resident identity cards, personal credit reports, work resumes (including education background, drug research and development work experience, etc.) and integrity commitments.
2. Documents related to the ability to bear responsibility for drug quality and safety.
(1) When applying for drug clinical trials, researchers shall submit a commitment letter on the risk and responsibility of drug clinical trials, promising to submit a guarantee agreement signed with the guarantor or an insurance contract signed with an insurance institution to the provincial drug supervision and administration department of their location before the clinical trials are carried out.
(2) When drug research and development institutions or researchers apply to become holders, they shall submit a commitment letter on the responsibility for drug quality and safety, promising to submit a guarantee agreement signed with the guarantor or an insurance contract signed with an insurance institution to the provincial drug supervision and administration department of their location before the drugs are put on the market; for injectable drugs, they shall promise to submit an insurance contract before the drugs are put on the market.
IV. Conditions for entrusted production enterprises
The entrusted production enterprises are drug production enterprises established in accordance with the law in the pilot administrative regions and holding a "Drug Production License" for the corresponding drug production scope and a drug production quality management specification (GMP) certification certificate.
5. Obligations and responsibilities of applicants and holders
(i) Perform the corresponding obligations of drug registration applicants and drug manufacturers in drug research and development registration, production, circulation, monitoring and evaluation as stipulated in the Drug Administration Law of the People's Republic of China (hereinafter referred to as the "Drug Administration Law") and other laws and regulations, and bear the corresponding legal responsibilities.
(ii) The holder shall sign a written contract and quality agreement with the entrusted manufacturer to stipulate the rights, obligations and responsibilities of both parties.
(iii) The holder shall entrust the entrusted manufacturer or qualified drug business enterprise to sell drugs on its behalf, stipulate the relevant sales requirements, urge it to comply with relevant laws and regulations, and implement the drug traceability management responsibilities.
(iv) The holder shall actively disclose drug marketing authorization approval information, drug instructions, reasonable drug use information, etc. through the Internet to facilitate public inquiries.
(v) If the approved drug causes personal injury, the victim may request compensation from the holder, or from the entrusted manufacturer, seller, etc. If the entrusted manufacturer or seller is responsible and the holder compensates, the holder has the right to seek compensation from the entrusted manufacturer or seller; if the entrusted manufacturer or seller is responsible and the holder compensates, the entrusted manufacturer or seller has the right to seek compensation from the holder. The specific implementation shall be in accordance with the provisions of the Tort Liability Law of the People's Republic of China.
VI. Obligations and Responsibilities of Entrusted Manufacturers
(I) Perform the obligations of drug manufacturers in drug production as stipulated in the Drug Administration Law and other laws and regulations, and bear the corresponding legal responsibilities.
(II) Perform the relevant obligations agreed with the holder in accordance with the law, and bear the corresponding legal responsibilities.
VII. Application of Holders
(I) Newly registered drugs.
For newly registered drugs after the implementation of this plan, if they meet the pilot requirements, the applicant can apply to become a holder at the same time as submitting a drug clinical trial application or a drug marketing application.
For drugs that have been accepted for clinical trial applications or marketing applications before the implementation of this plan but have not yet been approved for marketing, if they meet the pilot requirements, the applicant can submit a supplementary application to apply to become a holder.
If the applicant intends to entrust a trustee to produce the drug, the information of the trustee shall be submitted at the same time as the drug marketing application or supplementary application is submitted.
(II) Approved drugs.
For drugs that have been approved for marketing before the implementation of this plan, if they meet the pilot requirements, the applicant may submit a supplementary application to apply to become the holder.
If the applicant intends to entrust a trustee to produce the drug, the information of the trustee shall be submitted at the same time as the supplementary application.
(III) Change application.
After the holder's drug marketing application is approved, the holder may submit a supplementary application to change the holder and the trustee. In the stage where the drug clinical trial application or drug marketing application has been accepted but has not yet been approved, the applicant may submit a supplementary application to change the applicant and the trustee.
In the case of changing the holder or the applicant, the transferor and the transferee shall jointly apply to the provincial drug supervision and administration department of the transferee's location, and the provincial drug supervision and administration department shall report to the State Food and Drug Administration for approval; in the case of changing the trustee, the holder or the applicant shall apply to the provincial drug supervision and administration department of its location, and the provincial drug supervision and administration department shall report to the State Food and Drug Administration for approval.
(IV) Other requirements.
The approval documents of pilot drug varieties shall state the relevant information of the holder, entrusted production enterprise, etc., and indicate that the holder shall submit the guarantee agreement signed with the guarantor or the insurance contract signed with the insurance institution to the provincial drug supervision and administration department of its location in accordance with relevant requirements.
The instructions and packaging labels of pilot drug varieties shall indicate the holder information, production enterprise information, etc.
The drug approval number issued during the pilot work shall continue to be valid within the validity period stated in the drug registration certificate after the pilot period expires.
VIII. Supervision and management
(I) Post-marketing supervision.
The provincial drug supervision and administration department of the holder's location is responsible for the supervision and administration of the holder and the approved drugs. For entrusted production enterprises that are not in the administrative region, it shall jointly conduct extended supervision with the provincial drug supervision and administration department of the entrusted production enterprise's location. Strengthen the supervision and administration of the holder's performance of obligations such as ensuring drug quality, marketing and service, drug monitoring and evaluation, and drug recall, and urge the holder to establish a strict quality management system to ensure that responsibilities are fully implemented.
The provincial drug supervision and administration department where the production enterprise is located shall strengthen the supervision and inspection of drug manufacturers implementing production under drug GMP conditions, and take timely control measures if risks are found in the production and operation links.
If the drug supervision and administration department finds that the approved drugs have quality risks, it shall take risk control measures such as interviews, warning letters, rectification within a time limit, revision of drug instructions, restriction of use, supervision and recall of drugs, revocation of drug approval documents, and suspension of research, production, sales, and use against the holders and relevant units according to the actual situation.
For holders and entrusted production enterprises that violate the "Drug Administration Law" and other laws and regulations and the relevant provisions of this plan, the provincial drug supervision and administration department where the holder is located shall investigate and deal with them in accordance with the law and hold the relevant responsible persons accountable.
(II) Information disclosure.
The State Food and Drug Administration shall proactively disclose relevant information such as the acceptance, review, approval, and post-marketing changes of pilot drug varieties in accordance with regulations.
Provincial drug supervision and administration departments shall proactively disclose relevant information such as the performance of obligations by holders, daily supervision and inspection, and administrative penalties.
IX. Others
This plan will be implemented from the date of issuance until November 4, 2018. Pharmaceutical manufacturers in the pilot administrative area shall refer to the relevant provisions of the holder in this plan.
This plan shall be interpreted by the State Food and Drug Administration.
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