Overview of EU and U.S. PV Regulations and PV Regulation Trend after China Joined ICH--U.S.

In early September 2018, the National Medical Products Administration of China (NMPA) consecutively released announcements on revision of package inserts of four (varieties of) pharmaceutical products (2018 No. 58, 59, 62, and 63), to require revision of warning, [Adverse reaction], [Contraindication], [Notice] and [Pediatric drug] of package inserts of Wantong Jingu Tablets, glutathione injection, cold medicine that contains codeine, and Acanthopanax senticosus injection. By the time of this article, NMPA has released 28 announcements on revision of package inserts of pharmaceutical products, including a series of TCM injection, covering the closely watched Shenmai injection, Bupleurum injection, Salviae miltiorrhizae injection, Shuanghuanglian injection, Xuesaitong injection and Xueshuantong injection, etc.

Package insert revision is determined according to results of adverse reaction monitoring and assessment, and is in fact a part of the pharmacovigilance; it has been more than 1 year since the Chinese drug regulator joined ICH in June 2017; as the global pharmaceutical industry flourishes, investment in new drug development is made continuously, new technologies are applied, chances of cure and improvement of human diseases are growing, and the issue of pharmaceutical product safety receives more and more attention accordingly. Participating in the comprehensive international competition of global pharmaceutical industry, we must take active part in learning and making of international rules, thus to continue to enhance the innovation capacity and international competitiveness of China’s pharmaceutical industry. Today, let’s focus on the current management situations and development trends of Chinese and overseas pharmacovigilance under the global background.

The word "Pharmacovigilance" was originally used in France and it is combined by "Pharmakon" (meaning medicine, and pharmacy) and "Vigilance" (meaning alertness), and abbreviated as PV. WHO’s definition of PV is now commonly recognized: Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems.

U.S.

The U.S. FDA is one of the most authoritative drug regulators in the world that is committed to the safe and sound development of food and drugs of the country, and possesses a sound PV system. The U.S. PV regulatory system is divided into three layers: laws, regulations, and guidelines, to guarantee and promote the implementation and conduct of PV work from the source.

FDA’s PV work is mainly undertaken by the Center for Drug Evaluation and Research (CDER). CDER is mainly responsible for assessment of new drugs before marketing and supervision over pharmaceutical products on the market, and has Office of Surveillance and Epidemiology (OSE) and Office of New Drugs (OND) under it; OSE has three divisions under it: Division of Drug Risk Evaluation, Division of Medication Errors and Technical Support, and Division of Surveillance, Research, and Communication Support. Furthermore, FDA set up another institution in 2005: Drug Safety Oversight Board (DSOB), to be directly responsible to CDER and mainly settle disputes associated with adverse reactions of pharmaceutical products and formulate policy provisions on pharmaceutical product safety oversight.

There is a sound pharmaceutical product safety information and adverse reaction reporting system in the U.S. (MebWatch system). Refer to Fig. 1 for details of the labor division and collaboration of each division of FDA.

Related:

Overview of EU and U.S. PV Regulations and PV Regulation Trend after China Joined ICH--China

Overview of EU and U.S. PV Regulations and PV Regulation Trend after China Joined ICH--EU

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