"Administrative Regulations for the Filing of Raw Materials for Pharmaceuticals" for further comments

A few days ago, the State Food and Drug Administration again asked the community to solicit opinions on the Provisions for the Administration of the Filing of Raw Materials for Pharmaceutical Use (Consultation Draft).

After the “Administrative Provisions for Filing of Pharmaceutical Raw and Subsidiary Materials (Draft for Solicitation)” was solicited for comments on September 30, 2010, the State Food and Drug Administration conducted a summary and analysis of opinions and suggestions from various parties, and focused on opinions and suggestions. Several aspects have been revised and improved. With regard to the setting of the activation mechanism for filing numbers, feedback on the important activation mechanisms in the record management experience of foreign pharmaceutical raw and auxiliary materials has not been reflected in the original draft. After research, this revised draft sets the activation mechanism for the pharmaceutical raw material registration number. Set the record number activation mechanism to activate and publicize the raw and auxiliary material record numbers quoted after approval of the formulation registration. On the one hand, the public can understand the use of the raw and auxiliary materials for the record and the current status, and on the other hand, it can urge the filing units. Submit relevant raw and auxiliary materials update information in a timely manner. With respect to the issue of confidentiality of information where feedback is more concentrated, the new revised draft has been considered in the following ways. First, the establishment of a licensing mechanism for raw material manufacturers by raw material manufacturers was reinstated; second, the technical review authority must be authorized. The relevant confidential technical data may be linked to the review, and the regulatory authority is not authorized to use its confidential information. Thirdly, the confidentiality requirements of the information system and related operation guidelines are stipulated accordingly.