The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has announced that China’s National Medical Products Administration (NMPA) is officially seeking membership. This move signifies the NMPA’s intention to enhance communication and cooperation with PIC/S, aligning with international pharmaceutical inspection standards.
Historical Context and PIC/S Overview
PIC/S, formerly the Pharmaceutical Inspection Convention (PIC), was established by the European Free Trade Association in 1970. PIC/S operates as an international organization where member countries jointly sign and establish agreements. Due to EU system limitations, PIC/S emerged as an informal and flexible alternative for international cooperation in GMP, focusing on promoting international cooperation and standard consistency.
Differences Between PIC and PIC/S
| Feature | PIC | PIC/S |
|---|---|---|
| Official Level | Official agreements between countries | Non-state agreements |
| Legally Binding | Yes | No |
| Member Unit | Nations | Pharmaceutical GMP inspection institutions |
| Objective | Mutual recognition of inspection and certification results | Exchange and cooperation in the GMP field |
China’s Journey Towards PIC/S Membership
In December 2012, the former China Food and Drug Administration (CFDA) indicated preferential treatment for companies passing GMP inspections by PIC/S member units, including prioritized inspections and streamlined certification processes. Peking University School of Public Health initiated the “Feasibility Study on the Joining of the CFDA into PIC/S” in 2016, leading to preliminary recognition in 2021 after seven rounds of negotiations. The NMPA officially filed for pre-participation procedures in September 2021, aligning with the “Drug Regulatory Cybersecurity and Informatization Construction 14th Five Year Plan” released in May 2022.
PIC/S Membership Process and Implications
The PIC/S application process consists of “pre-application” and “formal application” stages, with a potential membership timeline of 3-6 years. Membership implies improved pharmaceutical production and quality management in China, enhanced drug regulatory capabilities, and mutual recognition agreements with other member countries regarding data. This step is expected to significantly benefit local innovative pharmaceutical companies by facilitating international recognition of inspections and clinical studies.- Flcube.com
