Yan is just one word! How do MAH and pharmaceutical companies implement the new "Drug Administration Law"?

The new drug administration law of the people's Republic of China (hereinafter referred to as the new drug administration law) has been revised and adopted by the 12th meeting of the Standing Committee of the 13th National People's Congress on August 26, 2019, and will come into force on December 1, 2019 On November 29, 2019, the official website of the State Food and Drug Administration issued a notice on the implementation of the drug administration law of the people's Republic of China (No 103, 2019 The new drug administration law adheres to the principles of risk management, whole process control and social co governance, and represents the opening of the most stringent regulatory era, which is both an opportunity and a challenge Every MAH and drug manufacturer need to think forward-looking about how to adapt to the changes of the new law and how to implement it? 1、 Pay attention to the preparation and revision of supporting regulations, normative documents and technical guidelines On November 29, 2019, the official website of the State Food and Drug Administration issued a notice on the implementation of the drug administration law of the people's Republic of China The State Food and drug administration is speeding up the preparation and revision of supporting regulations, normative documents and technical guidelines, which will be issued successively according to the procedures The author suggests that MAH and drug manufacturers should pay close attention to the following drug regulatory departments to prepare and revise supporting regulations Chapter, normative documents and technical guide list (including but not limited to) Focusing on the implementation of the requirements of the new drug administration law, the state drug administration system is working hard to formulate and revise a series of basic supporting rules, normative documents and technical guidelines for drug research and development, clinical practice, registration, production, operation and marketing, which will be implemented in an intensive and efficient manner, providing system guarantee for deepening drug regulatory reform After the implementation of the new drug administration law, the Don't emphasize the need to strengthen the in-process and post supervision Undoubtedly, in the context of the new regulatory era, the drug supervision system will effectively strengthen the in-process and post supervision, and effectively crack down on and punish illegal behaviors The author suggests that MAH and drug manufacturing enterprises should arrange in advance the study of the above drug supervision departments to prepare and revise supporting regulations, normative documents and technical guidelines, and carry out gap analysis 2、 Preparation and revision of quality management system documents The new drug administration law will come into force on December 1, 2019, which has made some new regulations on MAH and the quality system of drug manufacturing enterprises The author suggests that MAH and drug manufacturing enterprises should carry out gap analysis according to the requirements of the new drug administration law, and focus on the following systems in the quality management system If necessary, they should make revisions, including but not limited to the following systems: 2.1 Qualification change supplier management system After the implementation of the new drug administration law, no registration certificate will be issued for chemical APIs, pharmaceutical excipients and pharmaceutical packaging materials The original auxiliary package manufacturer will register on the original auxiliary package Registration Platform and conduct review and approval at the same time For MAH and pharmaceutical manufacturing enterprise preparation enterprises, some adjustments should be made to the registration certificate, GMP certificate, GSP certificate and other qualification requirements of suppliers (original auxiliary package manufacturer) 。 2.2 active reporting of enterprise information - annual reporting system The implementation of the annual report system in the new drug administration law will be more effective in the supervision of enterprises, enhance the initiative of drug listing license holders to disclose information to drug regulatory authorities, enhance the awareness of enterprises' social responsibility, promote self-discipline and social co governance of enterprises, and maintain good market order The annual report system at least includes: drug production and sales , post market research, risk management, etc., may also refer to the FDA guidance for Industry CMC postapproval manufacturing changes to be documented in annual reports, including minor changes in the production process of post market drugs, etc., and specific annual report system contents and report procedures suggest that the detailed rules of regulatory authorities be implemented as soon as possible 2.3 "drug ex factory release procedures" PK "drug listing release procedures" The new "Drug Administration Law" requires drug manufacturers to establish drug ex factory release procedures, and drug listing license holders to establish drug listing release procedures The State Drug Administration has released information By the end of July 2019, the database of drug listing license holders has been online, including 3239 varieties of listing license holders, 156 subjects of listing license holders At present, most of them Sub drug manufacturing enterprises are not only the holders of marketing license, but also drug manufacturing enterprises Generally speaking, the content of drug marketing release procedures and drug marketing release procedures can be put in one system, but the content should cover the requirements of Article 33 and Article 47 of the new drug administration law 2.4 understand the "past and present" system of products - drug traceability system drug traceability refers to the production, circulation and use of forward tracking and reverse tracking drugs through records and marks, The new drug administration law requires the establishment of a drug traceability system, the construction of a complete product quality file, the traceability of information data in the whole process of internal production quality of drug manufacturing enterprises, and the traceability of sales flow in the external market At the same time, it is clear that the enterprise is the main body responsible for product quality, and the realization of "traceable source, traceable destination and responsibility" It can be found that "consumers can see the" past and present "of drugs When quality problems occur, they can recall relevant products in time and find out the reasons This is the goal of establishing a traceability system In the future, the establishment of a traceability platform and the whole standardization system must also focus on this goal The State Food and drug administration has formulated and promulgated the standards for drug information traceability system Enterprises must be responsible for establishing and improving the drug traceability system, actively recording the basic information and transaction information of drugs, accepting the supervision of relevant departments, providing traceability information to the society and doctors and patients, establishing the whole process of drug information traceability system as soon as possible, realizing the data exchange across the country, and letting the people from the drug Obtain the sense of safety in the product traceability information.