Food and Drug Administration: Pharmaceutical Excipients Qualified for Inspection

On the 5th, the State Food and Drug Administration issued the "Relevant Regulations for Strengthening the Supervision and Administration of Pharmaceutical Excipients (Draft for Solicitation of Comments)" (hereinafter referred to as the "Draft for Comment"), and publicly solicited opinions from the public. The "Draft for Comment" requires that medicinal excipients must be qualified for inspection after being used in the production of drugs.

Pharmaceutical excipients refer to the excipients and additives used in the production of drugs and prescriptions. Medicinal excipients are an important part of drugs and can directly affect the quality and safety of drugs.

The "Draft for Comment" clearly stated that pharmaceutical manufacturers are responsible for the quality of pharmaceuticals. Pharmaceutical manufacturers must strictly control the use of excipients for the production of pharmaceuticals and audit suppliers. Purchased pharmaceutical excipients must be tested in accordance with the standard before being used to produce drugs. The “Draft for Soliciting Comments” emphasized that pharmaceutical preparation enterprises must produce drugs in accordance with prescribed prescription processes. If any changes occur, they should conduct research in accordance with the relevant regulations and perform change procedures.

The “Draft for Soliciting Opinions” regulates pharmaceutical excipients with reference to APIs and strengthens supervision:

The first requirement is that pharmaceutical excipients production enterprises organize production in accordance with the requirements of the “Quality Control Specification for Pharmaceutical Excipients Production” to increase the access threshold for production enterprises;

The second is to classify and manage supplementary materials according to the degree of risk, implement strict access systems for high-risk excipients and production enterprises, and strengthen risk control;

Thirdly, the new medicinal excipients must be reviewed in association with pharmaceutical preparations, emphasizing the inspection and audit responsibilities of drug manufacturers for new excipients, and further stricting the fixed sources and technical requirements for pharmaceutical excipients used in pharmaceuticals;

The fourth is to improve and improve the standard of pharmaceutical excipients as the current focus of work, which is conducive to the further improvement of the quality of pharmaceutical preparations.

The deadline for soliciting comments is June 8.