An In – Depth Look at the New Draft Proposal for the Administration and Management of Export Drug Production in China
The National Medical Products Administration (NMPA) has released a new notification soliciting public feedback on a set of rules related to the administration and management of export drug manufacturing. This move aims to further regulate the production of export drugs and ensure their quality and safety.
Draft Proposal Details:
The draft proposal provides clear definitions and requirements for export drugs. An export drug is defined as one manufactured by companies in China and exported to other countries (regions), including drug preparations and active pharmaceutical ingredients (APIs). The NMPA is responsible for the supervision and management of the production of export drugs nationwide. Provincial medical products administration departments conduct GMP compliance inspections on export drugs and mark “for export only” (or “for export”) in the dosage form and production line of the “Drug Production License” of the export drug manufacturer. Based on the manufacturer’s application and the supervision and inspection of the production of export drugs, export certification documents will be issued for export drugs.
The draft proposal has put forward requirements in several aspects for export drug manufacturers, including the production site, GMP compliance, co – production, packaging labeling, and circulation quality management. It also sets requirements for enterprises that accept commissioned production of export drugs regarding the qualifications of the commissioning party, import material management, and so on. Specifically, the prescription, production process, quality standards, packaging, and labeling of export drugs should be aligned with the requirements of the importing country (region). Export drug manufacturers are not allowed to accept commissions to produce blood products, toxic drugs for medical use, drug precursor chemicals, and compound preparations containing drug precursor chemicals for export. Those that accept commissions to produce narcotic drugs, psychotropic drugs, compound preparations containing narcotic drugs or psychotropic drugs for export must comply with relevant national regulations.
Record – keeping and Certification:
The draft proposal emphasizes the importance of record – keeping for export drugs. Export drug manufacturers are required to establish records and improve and timely update relevant information. Export certification documents, such as the “Certificate of Drug Export Sales” and the “Certificate of Export of EU Raw Materials”, are issued by the provincial medical products administration department where the drug is actually produced. The processing time limit for these documents is no more than 20 working days, and the validity period is no more than three years. Manufacturers can apply for new export certification documents six months before the expiration of the validity period. It should be noted that the relevant departments of the State Council shall not issue export certificates for drugs prohibited from export.
Conclusion:
The NMPA’s new draft proposal on export drug manufacturing administration and management is a significant step towards enhancing the regulation of the export drug industry in China. By seeking public feedback, the NMPA aims to ensure that the rules are comprehensive, practical, and in line with international standards. The implementation of these rules is expected to further improve the quality and safety of export drugs, promote the healthy development of China’s pharmaceutical industry in the international market, and enhance the country’s reputation as a reliable supplier of high – quality drugs.-Fineline Info & Tech
