On March 30, 2020, the State Administration for Market Regulation (SAMR) enacted the Amended Drug Registration Regulation (DRR) as part of its efforts to strengthen and streamline its regulation of the pharmaceutical industry. The DRR seeks, on the one hand, to further confirm a series of changes made in drug evaluation and approval in recent years, and, on the other, to implement in full a series of processes proposed in the Drug Administration Law (DAL), including who is authorized to…

Fangda Partners’ Josh Shin gives an overview of recent regulatory upgrades affecting the Chinese pharmaceutical industry.   On August 26, 2019, China enacted the Amended Drug Administration Law as part of its efforts to strengthen and streamline its regulation of the pharmaceutical industry. The amended law seeks to address prominent problems in the pharmaceutical industry, such as counterfeit drugs, substandard drugs and high drug prices. To address these problems and to accomplish other goals, the Amended Drug Administration Law will…

The key facts about regulatory reforms in Chinese pharma. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? There have been tremendous regulatory reforms in the pharmaceutical industry in the past three years, highlights of these reforms include: Marketing authorization system. The…

An outline of the legal situation around patents and trademarks for pharmaceuticals in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? Please refer to Question 3 below.   2. What agencies or bodies regulate patents and trademarks? In China, patents are regulated by…

A comprehensive guide to the legal implications around product liability in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for USD 99.   1. What types of liability are recognized in your jurisdiction? Violation of laws and regulations may result in civil liabilities, administrative penalties and criminal liabilities. Civil liability shall include: Discontinuance of infringements; Removal of obstacles;…

A legal intro to traditional medicines and OTC products in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional Chinese Medicine (TCM) is a system for diagnosis, prevention and treatment that has existed for thousands of years and is…

A brief overview of the situation regarding marketing, manufacturing, packaging & labeling and advertising within Chinese pharma. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Please refer to Questions 3 & 6 of the…

The essential requirements for conducting preclinical and clinical trials in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. According to the Technical Guidelines Governing Acceptance of Drug Clinical Data from Foreign Studies issued by NMPA…

An intro to the regulatory, pricing and reimbursement scenario for pharmaceuticals in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for USD 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Responsibilities for the administration of drugs (including biologicals) and medical devices are assumed by several governmental…