Chinese Pharmacopoeia & Standards

Drug quality standards are divided into statutory standards and corporate standards. The statutory standards are further divided into national pharmacopoeia, industry standards and local standards. The drug production should conform to the national pharmacopoeia; the production of drugs that have not been enrolled in the national pharmacopoeia should be in line with the industry standards; for those that have not been included both in the pharmacopoeia and the industry standards, the local standards need to be followed. The drugs, for which there are no statutory standards or which cannot meet the statutory standards, are not allowed to be produced, sold, and used in China.

The “Chinese Pharmacopoeia” provides the legal technical standards for supervising and managing the quality of drugs in China, and so to ensure the efficacy, safety, and quality controllability of drugs. The development of the “Chinese Pharmacopoeia” evolved together with the new China; from 1950 to 1980, three editions of the Pharmacopoeia were issued in China; since 1980, the Chinese Pharmacopoeia was amended every five years. The current version is the 2020 edition. As China became one of the ICH member countries (The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use), this revised 2020 edition, which used the experience of the international advanced drug standards as an invaluable source of reference and integrated the content of the drug standards implemented in other countries, is regarded as the "most rigorous standards" to date.

According to the regulations of the NMPA, if an overseas-manufactured drug has been enrolled in the “Chinese Pharmacopoeia”, it must meet its standards. However, in the technical review phase of the drug registration process, the regulatory requirements are much higher than the standards of the “Chinese Pharmacopoeia”, i.e., the regulatory requirements have integrated with the pharmacopoeia standards of many other countries in which the drug is also included; they are thus called the "most stringent review standards" in the world.

If you need to apply for marketing registration of a drug in China, you are welcome to contact Cisema for technical consultation. Cisema is proficient in confirming whether the overseas quality standards for abroad-produced drugs are consistent with the Chinese standards & requirements in the phase of technical review. In addition, after receiving the order and the necessary technical documents from customers, Cisema will report defects in their applications files in time; before the submission for registration, Cisema will provide a risk assessment to the clients in the first instance.

Registration of Foreign-produced Chemical Drugs in Class 1 & 2

The drugs in class 1 and 2 are innovative and modified new chemical drugs that have not been marketed both inside and outside China; for foreign-produced drugs which belong to these two classes, there are two main paths for the registration.

#1 Separate clinical trials in China: The first path is conducting separate clinical trials in China to support the marketing of the product. Before conducting a drug clinical trial in China, an IND-application (Investigational New Drug) is required. Within 60 days after the date of acceptance of such application, if the applicant does not receive any negative comments from the CDE, the clinical trial can be conducted in accordance with the submitted protocol, i.e., the applicant doesn’t have to wait for the approval letter from the NMPA (approval by default) thanks to an important recent law change. 

#2 Involving China in global clinical trials: The second path is involving China in the global development plan of the product at the very beginning or joining the MRCT (The Multi-Regional Clinical Trials). After the clinical trials are completed, the clinical data obtained from the MRCT can be used to support the NDA (New Drug Application) in China. However, in this case, it could also happen that a pharmacokinetic study that includes the Chinese population is required to be added.

In general, although the NMPA & CDE have promulgated many relevant measures and provisions, considering the special nature of drugs, the concrete regulatory situation of the registration needs to be analyzed according to the specific type of drugs.

Registration of Foreign-produced Chemical Drugs in Class 5 (5.1 & 5.2)

The class 5 (5.1/5.2) refers to the chemical drugs that have already been marketed outside China. For overseas-manufactured drugs that belong to this class, there are many regulations and guidelines available for reference.

In an effort to increase the availability of pharmaceutical treatments in China, the NMPA released, in July 2018, guidelines to allow pharmaceutical drugs that have already undergone clinical trials in other countries to enter the Chinese market without undergoing domestic clinical trials. In October 2020, the CDE issued the “Clinical Technical Requirements for Drugs Marketed Abroad but not Marketed Domestically”. Based on the overseas clinical data and on the urgency level of the domestic clinical demand, this regulatory document divides the drugs listed overseas but unlisted in China into three classes: 

A. Exemption from domestic clinical trials; 

B. Conducting necessary bridging trial and necessary exploratory and confirmatory clinical trials in line with the requirements for new drugs; 

C. Not approving clinical trials in China.

In all cases, Cisema can provide you advisory services on a case-by-case basis.