The Pharmacopoeia of the People’s Republic of China 2020 Edition (hereinafter referred to as the Chinese Pharmacopoeia) officially comes into force on Dec 30, 2020.
Since Dec 30, 2020, for all varieties of medicines that have been included in former versions of pharmacopoeia and standard promulgated by China bureau-level and ministerial-level units, if they are included in the 2020 edition of the Chinese Pharmacopoeia, their former standards shall be abrogated. For those varieties of medicines that have not been included in the 2020 edition of the Chinese Pharmacopoeia, their former versions of pharmacopoeia and standard shall still be implemented, but they shall meet the relevant general technical requirements in the 2020 edition of the Chinese Pharmacopoeia.
In China, according to the Pharmaceutical Administration Law, all medicines on the market should meet the relevant technical requirements in the Chinese Pharmacopoeia. Therefore, after Dec 30, 2020, the relevant application materials submitted by the enterprises for drug registration shall meet the relevant requirements in the new edition of the Chinese Pharmacopoeia.
For those registrations and applications that have been accepted by the Center for Drug Evaluation (CDE) by Dec 30, 2020, yet their technical evaluations have not been fully completed, drug regulatory departments will conduct evaluations and approvals according to the new requirements in the 2020 edition of the Chinese Pharmacopoeia. In cases where the applicant is required to provide additional technical information, the applicant shall submit all additional documents at one time. Medicines approved to be marketed before Dec 30, 2020, should also meet the relevant requirements in the 2020 edition of the Chinese Pharmacopoeia within 6 months after approval.
For medicines that have already by approved to be marketed, if the registered standards contain tesing items more than or different from those in the Chinese Pharmacopoeia, or if the quality acceptance criteria are more strict than those in the Chinese Pharmacopoeia, they shall, on the basis of meeting the requirements in the Chinese Pharmacopoeia, simultaneously implement the relevant items and criteria of the registered standards. However, medicines with registered standards containing fewer testing items than those in the Chinese Pharmacopoeia, or with less strict quality acceptance criteria, shall meet the requirements listed in the Chinese Pharmacopoeia.
For generic drugs that need to be evaluated for quality and therapeutic effect consistency, if the registered standards differ from those in the 2020 edition of the Chinese Pharmacopoeia due to the particularity of items like dissolution rate and drug release in quality control, enterprises applying for registration can offer advice for revising the national drug standards within three months after the approval of their application of registration. Before the Chinese Pharmacopoeia is revised, the enterprise can implement according to the approved registered standards of drugs.
In addition, if the Marketing Authorization Holder (MAH) and the manufacturing enterprise want to make changes to the drug prescription, production process, drug substances, excipients, and so on in order to meet the requirements of the 2020 edition of the Chinese Pharmacopoeia, they should refer to the change procedures required by the Measures for the Administration of Drug Registration.