In Mar. 2021, the Center for Drug Evaluation (CDE) under the China National Medical Products Administration (NMPA) released a total of seven announcements involving technical requirements for drug research & evaluation and reference listed drugs. Following are the keynotes summarized by the ChemLinked BaiPharm team.
1. Technical Requirements for Chemistry, Manufacturing, and Controls (CMC) Research and Evaluation of Overseas-marketed Chemical Drugs Without Domestic Marketing Authorization (Trial)1
On Mar. 8, CDE issued the Technical Requirements for Chemistry, Manufacturing, and Controls Research and Evaluation of Overseas-marketed Chemical Drugs Without Domestic Marketing Authorization. The document applies to (1) Chinese generic drugs whose original drugs have been approved abroad but not in China and (2) overseas-marketed drugs applying for China's marketing approval (except the overseas-marketed generic drugs whose original drugs are being marketed in China). The requirements are also applicable to active pharmaceutical ingredients (APIs) in linked applications with the drugs mentioned above.
Read more about the Technical Requirements at ChemLinked News.
2. The 41st Catalogue of Reference Listed Drugs (Consultation Draft）2
On Mar. 12, CDE released the consultation draft of the 41st Catalogue of Reference Listed Drugs. The list consists of 25 drugs with different specifications, such as Latanoprost and Timolol Maleate Eye Drops and Osimertinib Mesylate Tablets/Tagrisso. Among them, six are imported original drugs with China's marketing authorization, three are drugs with wide international recognition for equivalence to the original drugs, and 16 are original drugs that are marketed in the U.S., the European Union or Japan but not in China.
3. Guidance for Acceptance and Review of Changes to Traditional Chinese Medicine (TCM) (Trial) 3
On Mar. 12, CDE published the Guidance for Acceptance and Review of Changes to Traditional Chinese Medicine (Trial), which took effect on the same day. The guidance addresses supplemental applications that entail the reviews of NMPA, including those submitted during clinical trials. It specifies requirements for the application form, declaration materials and procedure for making changes to TCM.
4. Technical Guidelines for Chemical, Manufacturing and Controls Changes to Innovative New Drugs (Chemical Drugs) During Clinical Trials (Trial) 4
On Mar. 12, CDE published the Technical Guidelines for CMC Changes to Innovative New Drugs（Chemical Drugs）During Clinical Trials (Trial). The guideline applies to changes during the clinical trials of innovative or improved new chemical drugs (except radioactive drugs). To be specific, the changes have occurred or are going to happen to APIs or complete drug products in sample production, quality control, packaging, and storage during clinical trials.
In the guideline, CDE recognizes that it is reasonable to make substantial CMC changes to innovative new drugs in research and development (R&D). CDE also stated the general principle for drug changes: applicants should follow the risk assessment principle and conduct scientific evaluations on possible influences that could result from the changes based on the drug's clinical trial stage, properties, the applicant's existing recognition and initial studies on the changes. CDE also provides some examples of major changes in the guideline.
5. Technical Guidelines for Research on Topical Generic Drugs (Trial) 5
On Mar. 16, CDE released the Technical Guidelines for Research on Topical Generic Drugs (Trial). The guideline targets generic topical chemical drugs acting locally on the skin and sets forth technical requirements for CMC research, non-clinical trials, and bioequivalence studies. The dosage forms for external skin use in the guidelines include ointment, cream, gel, powder, solution and lotion, etc.
6. Technical Guidelines for Drug Immunogenicity Research 6
On Mar. 29, CDE issued the Technical Guidelines for Drug Immunogenicity Research to encourage and guide immunological research standardization. In the guideline, drug immunogenicity refers to the ability of a drug or its metabolite to provoke an immune response or immune-related event against itself or related proteins.
The guideline applies to therapeutic proteins, polypeptides or their derivatives, and drugs containing the substances mentioned above, e.g., antibody-drug conjugates. Other drugs with potential immunogenicity risks can also refer to the guideline.
The guideline mentions that applicants should choose candidate drugs with fewer immunogenicity risks as far as possible during drug development. On the other hand, they should explore how to reduce and control the adverse effects of immunogenicity.
7. Consultation Drafts of Three Technical Guidelines for Nanomedicines 7
On Mar. 31, CDE issued the consultation drafts of Technical Guidelines for Research on Quality Control of Nanomedicines (Trial), Technical Guidelines for Non-clinical Safety Studies on Nanomedicines (Trial), and Technical Guidelines for Non-clinical Pharmacokinetic Studies on Nanomedicines (Trial), asking for opinions and advice from the public.
In the three guidelines, nanomedicine refers to final nanomedicine products or nanoparticles that are made from APIs or combined from APIs and appropriate carriers using nanotechnology. The guidelines embody CDE's efforts in establishing nanomedicine regulatory standards and are expected to provide a scientific guide to the R&D of such medicines.
For more details of the technical documents mentioned above or any other pharmaceutical regulations in China, please consult BaiPharm through info@baipharm.com.
