Editor's Note: The monthly recap is intended to bring you the dynamics of recent major laws and regulations issued by China drug regulators, including National Medical Products Administration (NMPA) and the Center for Drug Evaluation (CDE).
1. NMPA Releases the 42nd Batch of Reference Listed Drugs
After the deliberation and confirmation of the panel of experts in quality and efficacy consistency evaluation of generic drugs, NMPA released the Catalog of Reference Listed Drugs (RLDs) (The 42nd Batch) on Jun. 25. This batch contains 67 drugs, including Ezetimibe and Simvastatin Tablets, as well as ω-3 Fish Oil Fat Emulsion Injection. The RLDs are selected to assess new generic drugs' bioequivalence.
2. NMPA Announces Requirements for Reporting Postapproval Changes to Biologics
On Jun. 18, NMPA published Postapproval Changes to Biological Products and Requirements for the Change Applications and Reports with immediate effect. The document provides information on reporting changes and requirements for reporting categories based on a three-tiered system for specific changes.
Reporting categories:
(1) Submit a supplemental application for changes to approved biologics.
Major CMC changes;
Major clinical changes;
Change of the Marketing Authorization Holder (MAH);
Starting to use a brand name (for a new drug that did not apply for using a brand name in its initial registration application);
Other conditions required by NMPA.
* Those who need to submit an application for the change should provide documents such as the drug approval certificate, a copy of its attachments, etc.
(2) File a record to NMPA (for overseas biologics) or local medical products administration (for domestic biologics).
Moderate CMC changes;
Moderate clinical changes;
Changes to the information recorded on the drug registration certificate;
Re-packaging of drugs imported from overseas and changes to the re-packaging;
Other conditions required by NMPA.
(3) Describe the changes in the annual report.
Minor CMC changes;
Minor clinical changes;
Other conditions required by NMPA.
3. CDE Implements the Guidance on Changes to Biological Products (Trial)
On Jun. 22, CDE issued and started implementing the Guidance on Acceptance and Review of Changes to Biological Products (Trial). The Guidance applies to biological products' supplemental application that entails the reviews of NMPA, including those submitted during clinical trials. The Guidance notes the key points in reviewing the application and specifies the necessary dossiers and the document formats.
4. CDE Adopts Technical Guidelines on Studies of CMC Change to Approved Biologics
On Jun. 25, CDE released the Technical Guidelines on Studies of CMC Changes to Approved Biologic Products (Trial) with immediate effect. The Guidelines sets requirements for studying chemistry, manufacturing and controls (CMC) changes to approved biological products.
The Guidelines lists the basic points for consideration in the studies:
MAH's responsibility and sustainable compliance;
risk evaluation and management of the change;
comparability study;
associated changes;
changes of excipients and packaging materials.
The most common three categories of changes are made to
drug substances;
drug products;
in vitro diagnostic (IVD) medical devices that are administered under the classification of biologics.
5. CDE Issues the 2020 Drug Evaluation and Approval Report
On Jun. 21, CDE released the 2020 Annual Report on Drug Evaluation and Approval. Last year, CDE completed the review and approval of 11,582 applications for traditional Chinese medicines (TCMs), chemical drugs and biological products, up by 32.67% comparing to 2019. 219 applications, including 42 for pediatric and rare diseases, got on CDE's priority review and approval track.
6. CDE Consults on the Work Procedure for Drug Changes During Review
On Jun. 23, CDE asked for public comments on the Work Procedure for Changes to Drug Registration Application During Review. CDE allows such change application to take place only once during each review, and the proposed change shall not influence the feasibility of reviewing and approving what the applicant originally applied for. Proper changes during review are permissible for Clinical application (CA), marketing application (MA), supplemental application and re-registration application.
7. CDE Consults on Guidelines on Clinical Studies of Antineoplastic Drugs, Chronic Myeloid Leukemia Drugs and Gene Therapy Products
In June, CDE solicited public opinions on the drafts of three guidelines:
(3) Technical Guidelines on Long-Term Follow-Up Clinical Studies of Gene Therapy Products.
These guidelines, without legally binding force, give advice in aspects like data collection and testing methods. CDE also recommends stakeholders to refer to ICH guidelines and other relevant guidelines published home and abroad.
8. CDE Consults on ICH Guideline on Testing for Carcinogenicity of Pharmaceuticals
As required by ICH, China, a member of ICH regulatory member, asks for national and regional public opinions on the Addendum to the Guideline on Testing for Carcinogenicity of Pharmaceuticals S1B (R1) and its Chinese translation. The Addendum is expected to promote the development of new small molecule pharmaceuticals by applying an integrative approach to human carcinogenicity risk assessment.
If you have any questions about the regulations above, please contact us via contact@chemlinkec.com. We would be glad to offer you answers and solutions.
