A series of pharmaceutical policy reforms have a profound impact on China's pharmaceutical industry. Whether it is to promote drug innovation, improve drug quality and efficacy, or reduce drug prices, it has a positive and far-reaching significance for all aspects.



The policy reform and pilot work are carried out in an orderly manner, including MAH pilot, generic drug consistency evaluation, Drug Association review, innovative drug priority review, and "4 + 7" pilot procurement with volume. It is planned to make separate legislation on vaccine management, revise the existing drug administration law, and issue the 2020 edition of the Chinese Pharmacopoeia, and solicit opinions on the relevant revised draft.



Coming soon: three key policies



In order to better ensure the safety and accessibility of drugs, some heavy pharmaceutical policies are in the pipeline, and will have a profound impact on the domestic pharmaceutical industry in the near future.



One



New version of drug administration law and regulations



It can be seen from the latest outflow draft that the requirements and strength of drug management will rise in an all-round way; a number of regulations related to drug marketing license holders, drug patents, and drug insurance systems have been added; the personnel structure of drug review has been optimized, and the professional level of drug review personnel has also been higher.



Two



Vaccine management act



In order to better monitor the whole process of vaccine development, production, circulation and vaccination, China plans to make separate legislation on vaccine management, establish a systematic and whole chain vaccine management system, highlight the characteristics of vaccine management, strengthen the risk management, whole process control, strict supervision and social co governance of vaccine, and ensure the safety, effectiveness and standardized vaccination of vaccine.



Three



Chinese Pharmacopoeia 2020 Edition



The time has come to 2019, and the publication date of the 2020 edition of the pharmacopoeia is getting closer and closer, and the compilation and calibration and verification work is close to the end.



According to the draft, it is estimated that there will be about 6400 varieties to be collected, including 220 varieties of traditional Chinese medicine, 420 varieties of chemical drugs, 30 varieties of biological products, 100 varieties of medicinal excipients and 30 varieties of drug packaging materials, with a total of about 800. The Pharmacopoeia has collected 1400 varieties, including 500 traditional Chinese medicines, 600 chemical drugs, 150 biological products and 150 pharmaceutical excipients.



We will strengthen the elimination of drug standards that have been cancelled, long-term non production, uncontrollable quality, unreasonable dosage forms, and low stability. We will further work out and revise the general rules of Pharmacopoeia, general principles of preparations, testing methods and guiding principles for all kinds of drugs from the horizontal and vertical perspectives, and gradually strengthen and improve the links related to drug research and development, production, circulation and use The general technical requirements and the construction of the guiding principle system.



Five report cards



Summary of drug acceptance



In 2018, CDE handled a total of 7336 drug registration applications (including excipients), an increase of 51.7% compared with 4837 in the same period last year. The main growth point is in drug supplementary application, which may be related to the deadline of 289 generic drug consistency evaluation and MAH pilot work at the end of 2018, and a large number of enterprises rush to apply before the deadline. Among them, 5969 chemical drugs, 413 traditional Chinese medicine, 923 biological products and 21 in vitro reagents were registered.





There were 682 new drug applications, an increase of 10.4% compared with 618 in the same period last year. There were 373 new chemical drug applications, 42 new drug applications for traditional Chinese medicine, and 264 new drug applications for biological products



As of October 17, 2018, CDE has released a total of 197 drug registration application lists in 8 batches to be included in the priority review procedure. The specific number of each batch is shown in Figure 3 (the 26th to 33rd batches in 2018). After November 7, 2018, the CDE issued a notice no longer to publicize the drugs to be included in the priority review procedure by batches, but adjusted to the on-site review method to organize experts to review and determine the priority review varieties.





In the whole year of 2018, a total of 336 varieties were included in the priority review list, an increase of 41.8% compared with 237 varieties in the same period of 2017, indicating that China's drug innovation ability and evaluation efficiency have been greatly improved.



Generic drug consistency evaluation



On March 5, 2016, the State Council officially issued a document to require the implementation of generic drug consistency evaluation, and determined the first batch of 289 chemical oral solid preparation varieties that must be completed by the end of 2018.



Since the announcement was released, a total of 1151 reference preparations in 19 batches have been released, and two batches of the catalogue of exempted or simplified human bioequivalence test (be) varieties were released on November 11, 2017 and July 31, 2018, covering 72 varieties in total.



By the end of 2018, the cumulative acceptance number of relevant conformity evaluation has reached 708, involving 205 varieties of 253 enterprises, 149 of which have passed or are deemed to have passed the conformity evaluation of generic drugs, but only 62 product specifications and 32 varieties in 289 catalogue have passed the conformity evaluation. Among them, 3 enterprises passed the product specification, 3 enterprises passed the product specification, and 1 enterprise passed the product specification. The pass rate of 289 varieties was 11.1%.



On December 28, 2018, the announcement of the State Drug Administration on the issues related to the quality and efficacy consistency evaluation of generic drugs and the announcement on matters related to the quality and efficacy consistency evaluation of generic drugs were issued. The varieties that passed the consistency evaluation were given priority to be included in the list, and the varieties that did not pass the consistency evaluation would be gradually transferred out of the catalog and included in the national basic fund The evaluation time limit is no longer set for the varieties of this drug list.



This means that the consistency evaluation of "289 list drugs" is delayed