Recently, Tieguai Liu attended the Guangdong Southern Medicine Summit Forum and had the honor to listen to a speech by the leaders of the Drug Administration. He learned that there are now more than 160 B certificates for drug production licenses in Guangdong Province. The advancement of the new version of the "Drug Administration Law" has indeed increased the enthusiasm of various institutions to obtain a B certificate for drug production licenses. It seems that as a research and development institution, if it does not obtain a B certificate, it will feel like it has no face. Recently, more and more enterprises, including drug sales enterprises, are also ready to move. As the owner of the B certificate, there is indeed a great advantage. Through obtaining approval documents through the organization, looking for a manufacturer to quote and manufacture drugs, the whole process is simple and perfect, and you can enjoy the fast track of centralized procurement and obtain a huge market opportunity. When something really goes wrong, B- card companies are asset-light and almost "zero risk" for investment bosses ".

At present, the drug administration department is gradually showing anxiety about the management of entrusted production MAH. For so many MAH enterprises and enterprises with C certificates, how to manage and control them in case of problems. The licensing office of the provincial bureau also revealed difficulties. Indeed, these B- card enterprises are like guerrillas one by one. They do not even have their own places (most of which are leased). Their ability to release and supervise products is far from that of traditional A- card or C- card enterprises. In order to obtain the certificate, some enterprises choose the quality authorized person, the person in charge of production and the person in charge of drug alert because of the cost of the enterprise and other reasons, some can not be full-time, some lack of ability, through the way of resume optimization of experience "beautification treatment" and so on, will pose risks to the final quality supervision of drugs.

Some new information recently obtained also shows that the drug administration department will strictly control the number of B certificates and at the same time control the issuance of C certificates. C card is a certificate that can be entrusted, but enterprises with C card can also produce their own. If a C- card enterprise does not have the experience of A- card, and the product is originally in the pilot stage, "factory release" is given to B- card enterprise for pilot or clinical use, and the team of B- card enterprise lacks the ability or is forced to release it to the market by "other factors", this management will indeed bring great risks.

Another regulatory risk is that the B- card and C- card enterprises are often not in the same province, and this is also the case in several cases currently done by Tieguai Liu, almost all of which are cross-provincial cooperation. Even if a B- card project is encountered at the same time for multiple C- card enterprises, but these enterprises are not in the same province, then as a regulator, it is also very headache. Whether it is the local supervision of C certificate or the local supervision of B certificate.

The monk is on one side and the temple is on the other. The monk is not under the control of this temple, so you can't catch the monk if you seize the temple. Seize the monk, the temple also does not necessarily compensate you. Because the monk had no money, the temple was not responsible for the problems that the traveling monk broke out outside.

As for the development direction of the laws and regulations, Tieguai Liu thinks: Certificate B will become more and more difficult, and Certificate C is not CDMO or CMO for every enterprise to be CDMO. CMDO or CMO enterprises have A certificate of experience will be an inevitable trend.

The following is an introduction to Certificate A, Certificate B and Certificate C, which are collected free of charge by interested partners.

Article 77 of the Measures for the Supervision and Administration of Drug Production, capital letters are used to classify drug marketing license holders and product types: A represents drug marketing license holders produced by themselves, B represents drug marketing license holders entrusted to produce, C represents drug manufacturers entrusted, and D represents drug manufacturers. Lowercase letters are used to distinguish preparation attributes: H represents chemical drugs, z represents proprietary Chinese medicines, s represents biological products, d represents in vitro diagnostic reagents managed by drugs, y represents Chinese herbal pieces, q represents medical gases, t represents special drugs, and x represents others.

A certificate of drug production license: A represents the holder of the drug marketing license produced by himself, and the approval document owner and the manufacturer are the same. Engaging in pharmaceutical production activities shall be approved by the pharmaceutical supervisory and administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located, and a pharmaceutical production license shall be obtained. Without a drug production license, no drug may be produced.

Drug production license B: B represents the drug marketing license holder entrusted with production. B card enterprises are different from pharmaceutical production enterprises. They do not engage in pharmaceutical production and need to commission production. The Marketing Authorization Holder (MAH) shall also apply for the Pharmaceutical Production License B in accordance with the regulations.

Drug Production License C: Drug Production License C represents an enterprise that accepts the entrustment of the owner of the drug approval document (I. e. the drug marketing license holder) to produce this variety of drugs. No matter whether the production enterprise has obtained the certificate or not, it needs to obtain the C certificate when accepting the entrusted production activities, and the certificate cannot replace it.

Drug production license D certificate: API manufacturers need to obtain D certificate before engaging in API production. From the perspective of parallel four certificates, it seems that they have rejected the MAH system of API that has been controversial before.