NMPA Issued the Announcement on Issues Pertaining to the Implementation of the Newly Revised Provisions for the Supervision and Administration of Drug Production
On March 31, 2020, NMPA issued the Announcement on Issues Pertaining to the Implementation of the Newly Revised Provisions for the Supervision and Administration of Drug Production (No. 47 of 2020), which reads as follows:
The Provisions for the Supervision and Administration of Drug Production (SAMR Order No. 28, hereinafter referred to as the Production Provisions) has been promulgated and will come into force on July 1, 2020. For better supervision of drug production, NMPA hereby announces the relevant matters as follows:
1. From July 1, 2020, applicants engaged in the production of preparations, APIs, and TCM slices should follow the relevant provisions of the Production Provisions while applying new for drug production licenses.
Applications for drug production licenses that have been accepted before July 1, 2020 but not yet approved afterwards shall be processed in accordance with the relevant provisions of the new Production Provisions.
The standards for on-site inspection and acceptance of production licenses shall comply with the relevant provisions of the Drug Administration Law of the People's Republic of China and its implementation regulations, and the relevant regulations of the Good Manufacturing Practice for Drugs. The scope of the Drug Manufacturing Certificate (License) shall specify the dosage form in the originals, and the workshop and production line in the copies.
2. The current Drug Manufacturing Certificate continues to be valid within the validity period. After the implementation of the Production Provisions, manufacturers' applications for alterations, renewal and re-issuance shall be reviewed in accordance with the relevant Production Provisions. While requirements are met, a new Drug Manufacturing Certificate shall be issued. The original validity period of alteration and reissuance remains unchanged, and the validity period of renewal is calculated from the current date of issuance.
3. Where the holders of drug marketing authorization (hereinafter referred to as MAH) who have obtained the Drug Manufacturing Certificate entrust the production of preparations, the provisions of Article 16 of the Production Provisions concerning changes to the production address or production scope shall apply. The company name, product name, approval number, validity period and other relevant changes of the entrusting parties shall be clearly stated in the copy of the Drug Manufacturing Certificate.
Where both entrusting parties are in the same province, the MAH shall submit relevant application dossiers to the local provincial drug regulatory authority, and the trustee shall cooperate with the holder to provide relevant materials. The provincial drug administration department shall review the application dossiers submitted by the holder, and conduct on-site inspections of the workshops and production lines where the trustee produces drugs, and make a decision for MAH to change production address, or production scope of the holder.
Where the entrusting parties are not in the same province, the trustee shall pass the on-site inspection of the drug production workshop and production line through the local provincial drug administration department, and cooperate with the holder to provide relevant application dossiers. The provincial drug administration department where the holder is located shall review the application dossiers submitted by the holder and make a decision to change the production address or production scope in accordance with the on-site inspection conclusion issued by the provincial department where the trustee is located.
Where the workshops or production lines involved in the entrusted production have not passed the compliance inspection of the Good Manufacturing Practice for Drugs drug production quality management standards (hereinafter referred to as GMP compliance inspection), the local provincial drug administration department should conduct a GMP compliance inspection.
4. The original approval documents for drug consignment production shall continue to be valid within the validity period. Upon implementation of the Production Provisions, if the Drug Manufacturing Certificate of either party is expired, changed, re-examined for reissuance or reissued, or the drug consignment production approval expired, the original entrusted production shall be terminated; and if the entrusted production shall continue, it shall be handled as per the Production Provisions concerning the change of production address and production scope and the requirements of this announcement. Approval documents for drug consignment production will no longer be issued separately.
5. For a manufacturer who obtains officially the Drug Manufacturing Certificate before July 1, 2020, and whose workshop or production line has not undergone GMP compliance inspection, it shall conduct GMP compliance inspection in accordance with the Production Provisions.
6. If the holder entrusts the production of a preparation, it shall sign with a qualified pharmaceutical manufacturer an entrustment agreement and a quality assurance agreement, the contents of which shall comply with the relevant laws and regulations. After NMPA releases the guidelines for the quality agreement on drug consignment production, both parties to the consignment shall complete and sign the entrustment agreement and quality agreement as required.
7. From the MAH pilot period to the starting of the newly revised Provisions for Drug Registration, the holders with marketing approval by entrusted production should apply for Drug Manufacturing Certificate to the local provincial drug administration department before July 1, 2020. The drug regulatory authorities at all levels shall, in accordance with the provisions of the MAH inspection procedures and key points, and their responsibilities, strengthen the supervision and inspection of the registration, production, operation and other links.
8. Drug administration departments at all levels should strengthen leadership, make overall arrangements, conduct effective publicizing and training concerning the Production Provisions in light of the actual work in the administrative region. It is necessary to fully implement the Four Strictest requirements of drug administration, strictly implement the laws and regulations, and reinforce the supervision of production links in accordance with the principle of territorial supervision, beef up crossprovincial production supervision and information notification, and make overall arrangements for 2020 Drug Manufacturing Certificate reexaminations, renewals and reissuances, to ensure that there is no reduction in administration efforts, standards, and continuous supervision, to ensure the quality and safety of medicines.
9. The Production Provisions and the relevant tables involved in this Announcement are shown in the attachment. Major problems encountered in the work shall be reported to NMPA in a timely manner.