The drug administration of each country has introduced their work plan for 2018 legislation or regulation revision and update, etc. in the spring of 2018. What will be the influences of those work plans on the pharmaceutical industry? Will they become opportunities or pressure? Pharmaceutical industry participants need to know the answers early and in more detail. Here, I’d like to summarize and analyze revision progress of those regulations in China, US and EU, in the hope of providing reference for the industry participants.
Progress of regulations in China
China Food and Drug Administration (CFDA) announced the 2018 legislative plan on February 12, 2018, wherein, 3 laws are involved: to continue to promote the introduction of the Amendment of the Drug Administration Law of the People's Republic of China; to continue to promote the introduction of the Decision of the Standing Committee of the National People's Congress on Authorizing the Implementation of Pilot Work of Patent Period Compensation System of Some Drugs and Exploration of Establishing Drug Patent Linkage System; to form the revised draft for review of the Drug Administration Law of the People's Republic of China and report it according to the procedure to the State Council of China for deliberation.
3 regulations are involved: to promote completion of revising the Regulation on the Implementation of the Food Safety Law of the People's Republic of China; to accelerate the revision of the Regulation on the Supervision and Administration of Medical Devices to strive to report the amendment draft to the State Council of China in the first quarter; to continue to promote the introduction of the Regulation on the Supervision and Administration of Cosmetics ASAP.
31 rules are involved: to formulate and revise 12 food supporting rules by centering on the Food Safety Law; to formulate and revise 15 medical devices rules according to the requirements for deepening the reform of the review and approval system of drugs and medical devices; to accelerate the construction of rule of law for food and pharmaceutical products, and formulate and revise 4 comprehensive rules.
What the pharmaceutical industry participants need to focus on is that they shall pay more attention to many drug-related regulations, wherein, MAH-related regulation has long been anticipated by the Chinese pharmaceutical industry—the Measures for the Administration of the Marketing Authorization Holders. Furthermore, the Measures for the Administration of Drug Registration will also be a hotspot the industry will focus on. Besides, the industry participants shall also focus on the following regulations: Drug Data Management Specification, Measures for Drug Inspections, and Measures for the Administration of Licensed Pharmacist Registration, etc.
Progress of regulations in the U.S.
The newly drafted or revised guidance the CDER of the U.S. FDA plans to issue in 2018 fiscal year involves the following 18 categories: advertising, clinical/antimicrobial, clinical/medical, clinical pharmacology, clinical/statistical, drug development tools, drug safety, electronic submissions, generics, labeling, over-the-counter, pharmaceutical quality/microbiology, pharmaceutical quality/CMC, pharmaceutical quality/manufacturing standards (CGMP), pharmacology/toxicology, procedural, rare diseases, and user fees. See the following table for the details:
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