Breaking News: NMPA Issued Temporary Provisions on Overseas Inspection of Cosmetics for Public Comments

In order to strengthen the supervision of imported cosmetics, National Medical Product Administration (NMPA) will organize the on-site inspection of imported cosmetics manufacturers. In line with the principle of fair competition and consistency at home and abroad, NMPA, refer to the relevant work procedures for overseas inspection of pharmaceutical and medical devices, started to draft the Temporary Provisions on Overseas Inspection of Cosmetics (hereinafter referred to as the PROVISIONS) in May 2019. Now the PROVISIONS are issued for public opinion from Nov 22 to Dec 22, 2019. Relevant entity and individuals can feed back their opinions to hzpjgc@nmpa.gov.cn with the title "Temporary Provisions on Overseas Inspection of Cosmetics” as the email subject.

The PROVISIONS contain 5 chapters, 36 articles and 6 attachments.

Chapter I General Provisions (Articles 1 to 8)

Chapter II Inspection Plan and Preparation (Articles 9 to 15)

Chapter III Inspection Implementation (Articles 16 to 24)

Chapter IV Audit and Processing (articles 25 to 33)

Chapter V Supplementary Provisions (Articles 34 to 36)

Main Contents of General Provisions

• Definition of Overseas Inspection of Cosmetics

It refers to the overseas on-site inspection carried out by the NMPA to confirm the authenticity, reliability and compliance of the overseas development, production process and the application materials of cosmetics.

• Competent Authorities

NMPA: responsible for the management of overseas inspection of cosmetics.
Center for Food and Drug Inspection of NMPA (hereinafter referred to as CFDI) : responsible for the specific organization and implementation of overseas inspection of cosmetics.

• Inspection requirements, basic information and processing results are open to the public.
• Inspectors keep state secrets, work secrets and secrets of the inspected units

Main Contents of Inspection Plan and Preparation

● Based on the principle of risk control, the overseas inspection plan focus on the enterprises with the issue of product registration (filing), inspection, adverse reaction detection, complaint reporting and having big quantity of import, more consumers and higher impact in the domestic market. Safety risk factors include:

1. Potential risks are found in the review and approval process;
2. The inspection results are not compliant with the indication of safety risks in the quality system;
3. Adverse reaction monitoring indicates potential safety risks of products;
4. Complaints or other clues indicate violations of laws and regulations;
5. The registration/filing applicant has bad records or dishonest conduct;
6. The public information from the overseas regulatory authority indicates having greater risk of the quality management system or the products of the registration/filing applicant
7. Others required for overseas inspection.

● Overseas Inspection Plan Process

The working language of overseas inspection shall be Chinese, and the application materials, rectification reports and other materials submitted by the registration/filing applicant shall be Chinese version. Translators should be available during the inspection.

Authorized Agent of Overseas Inspection： A registration/filing applicant designates one domestic institution (its branch, office or agent in China).

The agent shall be responsible for the liaison between the competent authority and the registration/filing applicant, the monitoring of adverse reactions of cosmetics, the product traceability and recall, etc. The agent shall fulfill the relevant responsibilities and obligations of cosmetics marketed in China as stipulated by laws and regulations, and assist the competent authorities in the inspection of overseas product development and production sites, as well as the investigation and punishment of illegal behaviors.

Main contents of inspection implementation

Work flow of overseas inspection

The inspection team generally composes of 3 to 5 inspectors, and adopts the leader responsibility system. The inspectors shall be supervisors who have the national inspector qualification. The inspectors shall sign the statement of no conflict of interest and the letter of commitment of confidentiality and inspectors.

Main contents of audit and processing

Review process of overseas inspection results

The principle of risk assessment shall be adopted in the comprehensive evaluation, and considering the defect nature, severity and frequency, and the product category comprehensively. The judging principle is as follows:

1. Qualified: no defects or only minor defects are found in the on-site inspection.
2. Qualified after rectification: the rectification measures for all serious and general defects found in the on-site inspection show that the registration/filing applicant can take effective measures to correct and organize production in terms of regulations and technical specifications.
3. Unqualified: there were authenticity problems found in on-site inspection, key factors affecting product quality were inconsistent with the registration or filing data. The production quality system had more than 5 (including 5) serious defects or more than 20 (including 20) general defects in the light of Inspection Key Points of Cosmetics Production License, and the rectification work was not in place, others which did not meet the requirements of laws, regulations and technical specifications.

In case of any of the following circumstances, it shall be deemed that the registration/filing applicant delays, hinders, restricts or refuses the inspection, and it shall be directly judged as "UNQUALIFIED":

1. Failing to provide qualified authorization file of the agent or other required documents within the prescribed time limit after the delivery of the Notice of Overseas Inspection;
2. The registration/filing applicant refuses or twice postpones the scheduled inspection;
3. Failing to go through formalities for overseas inspection;
4. Delaying, hindering, restricting or refusing the inspectors to enter the inspected place or area, or restricting the inspection time, setting unreasonable inspection conditions or interfering with the inspection, or failing to arrange dynamic production as requested;
5. Delaying, refusing to provide or deliberately concealing key inspection information;
6. Refusing or restricting the inspectors to collect related information of evidence; or
7. Other circumstances in which the inspectors do not cooperate in the inspection.

Main contents of the supplementary provisions

The PROVISIONS are applicable to the on-site inspection of the product development and related processes of production of the registration/filing applicants in Hong Kong, Macao and Taiwan.

Attachment list

1. Notice of Overseas Inspection of Cosmetics
2. Relevant Requirements for the Authorized Agent of Overseas Inspection by the Registration or Filing Applicant of Cosmetics
3. Basic Information Form of Cosmetics Products for Overseas Inspection
4. Cosmetics Production Site Main File List
5. Pre-Notification of Overseas Inspection of Cosmetics
6. Notice of Overseas Inspection Results of Cosmetics

The detailed contents of abovementioned attachment can be found by sending the email to april.guo@cirs-reach.com

CIRS Comments

1) According to Article 52 of Cosmetics Supervision and Administration Regulation (Draft), it is mentioned that NMPA can carry out on-site inspection on the authenticity of the registration materials of imported cosmetics and whether the overseas production enterprises meet the requirements of the cosmetics production quality management standards. The PROVISIONS will be regarded as a supporting regulatory document for the upcoming Cosmetics Supervision and Administration Regulation.

2) The responsibilities of the overseas inspection agent are the same as those of the domestic responsible person for import non-special cosmetics. However, it is different from the responsible person for the registration of imported special products in China.

3) NMPA gradually unifies the post-surveillance mode and requirements for domestic and imported cosmetics.

4) Overseas inspection is based on the principle of risk control, and products or enterprises within the following scope will be the priority of selection by the government: a) products with authenticity, reliability and compliance risks in product registration/filing materials; b) products with high market popularity; c) products with large import volume; d) products with high safety risks, such as baby care, whitening, sunscreen, hair dye, etc.; e) enterprises with poor credit; f) famous brand enterprises.

Source： http://www.nmpa.gov.cn/WS04/CL2103/371425.html