Legal & Regulatory > China

Key legal info on biosimilars & biologics 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 GBP 119.   1. Are biosimilar medicines considered the same as generic medicines in your country? The basic principles of research and evaluation of biosimilar medicines are similar to that of generic medicines, but the regulation in practice is different. Biosimilar medicines…

Want to know more about localization 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 GBP 119.   1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? Yes. The key regulations are the Pharmaceutical Administration Law (药品管理法) and the Regulations for the…

An intro to the legal situation for orphan drugs and rare diseases 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 GBP 119.   1. What is the definition of Rare Diseases in your country? As of now, there is no definition of Rare Diseases in China. The List of Rare Diseases (罕见病目录) promulgated by the National…

Cannabinoid drugs, medicinal cannabis & opioid drugs in India – a comprehensive legal overview. 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 GBP 119.   CANNABINOID DRUGS 1. Are Cannabinoid Drugs authorized in your country? Cannabinoid Drugs are not authorized in China.   2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs? N/A   3. Is there…

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 GBP 119.   1. Are there proposals for reform or significant change to the healthcare system? Reform of Medical Insurance Payments To improve the cost-effectiveness of the current healthcare system, pilot policies of Diagnosis-Related Groups (“DRG”) payments have been implemented…

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 GBP 119.   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 GBP 119.   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 can include: Desistance from infringement; 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 GBP 119.   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 GBP 119.   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 GBP 119.   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 the…

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 GBP 119.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Several governmental agencies are responsible for the administration of drugs (including biologicals) and medical devices, including…

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…