The National Medical Products Administration (NMPA) has issued a notice detailing new supervision and management measures for the outsourcing of manufacturing duties by Marketing Authorization Holders (MAHs). These measures take immediate effect and aim to enhance the regulatory framework surrounding drug production outsourcing.
Regulatory Requirements for Outsourcing
Applicants seeking to outsource drug manufacturing must apply for a drug production license, referred to as a Class B license, or amend an existing license through provincial drug regulatory departments. The provincial Medical Products Administration (MPA) bureau where the outsourced production enterprise is located will issue a Good Manufacturing Practice (GMP) compliance inspection notice.
Guidance for Applicants
The drug regulatory department provides guidance for applicants to apply for the issuance of a drug production license or an increase in production scope. This process occurs after completing pharmaceutical, pharmacological, toxicological, and clinical trials that support drug registration. Applicants must also determine quality standards, complete commercial scale production process validation, and prepare for drug registration verification and inspection.
Encouragement for Self-Production and Technological Advancements
The document encourages biological MAHs to have the capability to produce their own products. Pharmaceutical production enterprises entrusted by biological MAHs are prioritized if they utilize information technology to record all data during production and inspection processes. Additionally, holders of multi-component biochemical drugs are encouraged to establish their own production raw material bases and strengthen control over the production process of animal-sourced raw materials.
Restrictions on Outsourced Production
The notice specifies that certain products, including blood products, anesthetic drugs, psychotropic drugs, toxic drugs for medical use, and pharmaceutical precursor chemicals, shall not be commissioned for production in accordance with the law. Similarly, compound preparations containing anesthetic drugs, psychotropic drugs, and precursor chemicals are prohibited from being outsourced for production as per relevant regulations.-Fineline Info & Tech
