On May 28, China National Medical Products Administration (NMPA) issued Administrative Measures on Drug Inspection (Trial) with immediate effect.1
The Administrative Measures displaces two former regulations on drug inspection—Administrative Measures on the Certification of Good Supply Practices (GMP) for Drugs and Administrative Measures on the Certification of Good Manufacturing Practices (GSP) for Drugs.
China has cancelled the GMP and GSP certification since it implemented Drug Administration Law2 on Dec. 1, 2019. Now, the drug manufacturing and supply activities in the country will be inspected according to Administrative Measures on Drug Inspection (Trial).
1. Application Scope
The Administrative Measures applies to drug regulators' activities to inspect, investigate, collect evidence of and deal with the production, supply and usage of licensed drugs in China.
For overseas manufacturing sites, drug regulators will conduct inspection according to Administrative Provisions on Overseas Inspection of Drugs and Medical Devices3.
2. What's Drug Inspection
Drug Inspection refers to drug supervision and administration departments' activities to inspect whether the companies engaging in drug production, supply and usage
abide by laws and regulations
carry out quality management practices
and follow relevant standards.
3. Types of Inspection
There are four different types of drug inspection in China: pre-approval inspection, routine inspection, for-cause inspection and other inspections.
3.1. Pre-approval Inspection
Pre-approval inspection focuses on confirming whether the applicants who manufacture or supply drugs are qualified to carry out these activities. It has two sub-types, one for manufacturing, the other for supplying.
3.2. Routine Inspection
(1) Routine inspection is conducted according to drug supervision and administration departments' annual inspection plan. The regulators supervise and inspect whether drug marketing authorization holders (MAHs), manufacturers, suppliers and institutions that consume medicines
obey relevant laws and regulations,
follow relevant standards,
and carry out good manufacturing practices.
(2) Drug supervision and administration departments will manage the inspections according to different levels of risks. Risks will be assessed considering the following factors:
characteristics and the intrinsic risks of the drug product;
the drug sample inspection result of MAHs, manufacturers, suppliers and institutions consuming medicines;
whether there is illegality with MAHs, manufacturers, suppliers and institutions using medicines;
the adverse drug reactions (ADRs), investigational research, complaints and reports, and other clues that may indicate potential risks.
(3) Routine inspection contents:
whether the inspected company obeys drug administration laws and regulations;
whether the company implements relevant drug quality management practices and follows relevant standards;
authenticity and completeness of the materials and data of ① drug production, ②supply and ③ usage;
MAHs' capability in quality management and risk prevention & control;
other contents considered necessary by drug supervision and administration departments.
- No less than once every quarter for companies producing anesthetics, Class 1 antipsychotic drugs and precursor chemical drugs.
- No less than once half a year for manufacturers of Class 2 antipsychotic drugs and anesthetics, as well as regional wholesalers of Class 1 antipsychotic drugs and active pharmaceutical ingredients (APIs) of precursor chemical drugs.
- No less than once a year for manufacturers and suppliers of radioactive drugs and toxic drugs for medical use.
Note: Companies may not be notified by inspectors in advance for routine inspection.
3.3. For-cause Inspection
(1) For-cause inspection is a targeted investigation on specific possible or reported problems with drug MAHs, manufacturers, suppliers and institutions using medicines.
Note: Companies won't be informed by drug inspectors in advance.
3.4. Other Inspections
Other inspections refer to inspections other than the three types mentioned above.
4. Drug Inspection: Conclusion, Feedback and Correction
4.1. Conclusion of Drug Inspection
Inspection institution which sends out personnel to carry out the inspection task should review the on-site inspection report within the required time and conclude a comprehensive evaluation. The inspection institution will then send the Comprehensive Evaluation Report on Drug Inspection to drug supervision and administration departments. The report includes:
MAH's information: company name and address;
source of the inspection task;
specific inspectors who carried out the task;
problem or deficiency found in the inspection;
conclusion of the comprehensive evaluation, etc.
4.2. Feedback on Drug Inspection
The drug supervision and administration departments will inform the inspected companies of the conclusion of the Comprehensive Evaluation Report on Drug Inspection.
4.3. Correction after Drug Inspection
After the on-site inspection, the inspected company should correct the deficiencies within 20 workdays. If the 20-day period is not enough for rectification, the company has to formulate a feasible and practical correction plan and submit it to the inspection institution.
The correction plan should include at least the following contents:
description of the deficiency;
investigation and analysis of the deficiency;
risk control plan;
review of the correction.
After implementing the plan, the company should send a supplemental report on the correction result to the inspection institution.
5. Time Limit for Drug Inspectors and Administrations
6. Punishment for Illegality, Deficiency and Uncooperative Actions
If the Comprehensive Evaluation Report on Drug Inspection concludes that a company fails to fulfill relevant requirements, drug supervision and administration departments will immediately take measures such as suspending drug production, sales, use and importation.
If a drug company refuses or escapes inspection, or forge, destroy or hide relevant evidence, its products will be considered to have possible safety problems. These situations will be disposed according to the Article 99 of China's Drug Administration Law.
7. BaiPharm's Advice for Industry
The Administrative Measures on Drug Inspection (Trial) shows China's determination and actions to crack down illegality and ensure drug quality. Pharmaceutical companies should guarantee that their businesses operate within the law and their products are up to standard. After all, for-cause inspection could come at any time. For more details in the Administrative Measures on Drug Inspection (Trial), please contact us through firstname.lastname@example.org.