Notice of the Department of Drug Safety Supervision of the State Food and Drug Administration on the solicitation of opinions on the "Administrative Measures on Inspection of Overseas Pharmaceutical Production Enterprises"

All relevant units:

In order to standardize the inspection of overseas pharmaceutical production companies, the State Administration has drafted the “Administrative Measures for Inspection of Overseas Pharmaceutical Production Companies” (draft for solicitation of opinions). The consultation draft is now publicly solicited on the website of the State Bureau. Any opinions or suggestions from any unit or individual should be reported to the Department of Drug Safety Supervision before October 8, 2012.

Contact: Ye Jiahui Telephone, 88330854

Fax E-mail: ajgmp@sda.gov.cn

Measures of the Administration of Inspection of Overseas Pharmaceutical Manufacturers on August 20, 2012 of the State Food and Drug Administration Drug Safety Supervision Division (Trial) (Draft for Comment)

Article 1 These Measures are formulated in accordance with the relevant provisions of the Drug Administration Law, the Regulations for the Implementation of the Drug Administration Law, and the State Council's Special Provisions on Strengthening the Supervision and Administration of the Safety of Food Products, etc., and are used to regulate the inspection work of overseas pharmaceutical manufacturing enterprises. .

Article 2 The inspection of an overseas pharmaceutical manufacturing company is an inspection of the import pharmaceutical production site organized by the State Food and Drug Administration during the period of registration review, approval, or having obtained a marketing permit, aiming to strengthen the supervision and management of imported pharmaceuticals and standardize the importation. Drug production practices ensure the quality and safety of imported drugs.

Article 3 This measure applies to all overseas pharmaceutical manufacturers that have obtained the "Imported Drug Registration Certificate" or "Pharmaceutical Product Registration Certificate" issued by the State Food and Drug Administration, and is applying to the State Food and Drug Administration "Import Drug Registration Certificate". "Or "medical product registration certificate" overseas pharmaceutical production enterprises.

Article 4 The State Food and Drug Administration shall, on the basis of registration review, daily supervision and management, port inspections, and reports from the public, determine the list of overseas pharmaceutical production enterprises and species that need to be inspected on site, and advance the inspection time and other relevant information. Inform the overseas pharmaceutical manufacturing companies in the offices in China or their entrusted agencies in China (hereinafter referred to as agencies).

Article 5 The agency is responsible for communicating with overseas drug manufacturers, and is responsible for submitting the requested relevant information to the Drug Certification Administration Center of the State Food and Drug Administration in a timely manner. Detailed information requirements are shown in the annex.

Article 6 If an overseas pharmaceutical manufacturing enterprise does not have a special reason to postpone the on-site inspection after receiving the on-site inspection notice, its agency shall submit a written application to the State Food and Drug Administration Drug Certification Management Center and explain the reasons. For enterprises that refuse to carry out on-site inspection or do not cooperate with the on-site inspection without reason, it is deemed that the on-site inspection fails.

Article 7 The foreign drug manufacturing enterprises that are inspected shall arrange for the mass production of the inspected products during the on-site inspection.

Article 8 On-site inspection shall adopt the leader responsibility system. The inspection team generally consists of 2-5 inspection personnel.

Article 9 The first meeting of the on-site inspection shall be presided over by the leader of the inspection team, confirm the inspection scope, inspection schedule, and company escort personnel; declare the inspection of discipline and precautions.

Article 10 The main contents of the on-site inspection include: the consistency of the application documents for drug registration, on-site information and the actual production process; and the conformity of the drug production process with the “Standards for Quality Control of Pharmaceutical Production (2010 Revision)”.

Article 11 The overseas drug manufacturers that are inspected shall provide the relevant materials required for the inspection in a timely manner. According to the needs of the inspection work, the inspector may take photographs, video and other measures to collect evidence. If the company refuses to take pictures or take pictures, the inspector should specify the situation in the inspection report. When necessary, inspectors can take samples and bring them back to the territory for inspection.

Article 12 After the on-site inspection is completed, the inspection team shall analyze and summarize the on-site inspections and determine the defective items of the enterprise. During the analysis and summary period, company escorts should evade.

The thirteenth meeting of the last meeting of the inspection team to the inspection of overseas pharmaceutical production companies oral feedback inspection found in the defective items. If an overseas pharmaceutical production enterprise that has been inspected has any objections to be explained, the inspection team may further verify the situation if necessary, and modify the defective item according to the verification results.

Article 14 Within two months from the end of the on-site inspection, the State Food and Drug Administration Drug Certification Administration Center will report the written on-site inspection report to the agency. For those enterprises whose on-site inspections do not have obvious defects or whose defects can be rectified immediately, the SFDA Drug Certification Administration Center will no longer report the written on-site inspection report to the agency and deal with the relevant provisions of Article 15 directly.

Within one month after receiving the on-site inspection report, the agency is responsible for submitting the rectification report of the inspected company to the State Food and Drug Administration Drug Certification Management Center. For special reasons, if it is impossible to submit a rectification report within the prescribed time limit, it shall apply to the State Food and Drug Administration Drug Certification Management Center in advance and clarify the time limit for submitting the report. However, the time limit for extension shall not exceed one month.

Article 15 Within one month after receiving the rectification report submitted by the agency, the State Food and Drug Administration Drug Certification Administration Center shall comprehensively evaluate the inspection situation according to the principle of risk management. The inspection conclusions are divided into "conformity requirements", "according to requirements after rectification" and "does not meet the requirements." The principle of determination is as follows:

I. Pharmaceutical production and quality control are consistent with the application data and can be organized in accordance with the GMP requirements of pharmaceutical products, and are judged to be “according to requirements”.

Second, the on-site inspection found a number of major defects. The submitted rectification report showed that after the rectification, it was able to organize the production according to the GMP requirements of the drug, and it was judged as “according to the requirements after rectification”.

Third, the on-site inspection found that the falsification or affecting the quality of the product is inconsistent with the declaration of the key elements; there are serious defects or a number of major defects, indicating that the inspection unit can not organize production according to the GMP requirements of the drug, the inspection conclusion is judged as "does not meet the requirements" .

When necessary, the State Food and Drug Administration Drug Certification and Administration Center may organize inspectors to recheck the company's rectification.

Article 16 For those enterprises whose inspection conclusions are "according to requirements" and "according to requirements after rectification," the State Food and Drug Administration shall, within one month after the conclusion of the inspection, submit feedback to the agency in writing.

For enterprises that have concluded that they do not meet the requirements, the State Food and Drug Administration issues a "warning letter" to the agency and orders them to suspend the import of the drug or suspend their drug registration review and approval process until the next site. Check meets requirements. At the same time, they notified the food and drug administrations of all ports and suspended the "Customs Clearance of Imported Drugs". For drugs that have been imported, the State Food and Drug Administration has, on the basis of the severity of the circumstances, ordered the company to recall drugs or other disposal decisions.

Article 17 Under special circumstances, when an on-site inspection finds that there is a serious defect in the overseas drug manufacturing company being inspected and seriously jeopardizes the safety of the public's medication, the State Food and Drug Administration may immediately make the relevant decision of the 16th paragraph.

Article 18 The present Measures shall be implemented as of the day of the year, and the State Food and Drug Administration shall be responsible for the interpretation.

Attachments: Specific Information Requirements The following information is required in duplicate, printed and bound on A4 paper.

First, the site master file The site master file content includes the enterprise's overall situation, production quality management system, personnel, plant and equipment, documents, production, quality control, distribution, complaints, product defects and recalls, self-inspection and other nine aspects. The specific requirements are written according to the latest requirements of the PIC/S site master file. This information is required to be expressed in Chinese. Some of the chart contents are allowed to be filled out in English.

2. The basic conditions of imports of imported drugs into China in the last three years include the number of imports of the species in each of the past three years, port inspections, adverse reactions, product complaints, and product recalls. In the event of a complaint due to quality reasons or recall of the product, it is necessary to specify in detail the cause of the complaint or product recall and the final disposal. Request that the information be expressed in Chinese. If the species is applying for the "imported drug registration certificate" or "medical product registration certificate" of the State Food and Drug Administration, this information may not be submitted.

3. The basic conditions of production and sales of imported drugs in other countries in the world in the past three years include whether they were stopped from importing and selling because of non-compliance with GMP in other countries, and whether the products were recalled for quality reasons. If any of the above conditions occur, the specific reasons and the final disposal must be specified in detail. Request that the information be expressed in Chinese. If the product is not listed in other countries, this information may not be submitted.