China National Drug Administration 3 Stipulation Scheme Unveiled

Takehome:

• 3 Stipulation Scheme clarifies the responsibilities and division of labor between the newly formed SAMR and subordinate CNDA departments.
• A Cosmetic Safety Supervision Department is newly established.
• Compliance requirements mandating registration of all imported non-special use cosmetics will be gradually phased out and replaced by new filing requirements. Classified management will be implemented on new cosmetic ingredients.

China National Drug Administration is under the governance of SAMR. CNDA consists of 9 subordinate departments, including a “Cosmetic Safety Supervision Department”(化妆品监督管理司), which will undertake cosmetics registration and filing, drafting and supervising the implementation of cosmetic standards, classification rules, technical guidelines and censorship, as well as conducting on-site and sampling inspection, penalizing illegal activities and monitoring adverse reactions.

Cosmetics and drugs differ greatly in the inherent risks they pose and obviously in associated regulatory requirements, but in the past have been overseen by the same regulatory department. The establishment of the Cosmetics Safety Supervision Department indicates the increased prioritization of cosmetics regulation. An industry expert also points out that at a provincial level, the cosmetics supervision department may function autonomously.

CNDA major responsibilities include:

1. Safety Supervision Management

CNDA is responsible for cosmetics, drug and medical devices' safety supervision management, including formulating supervision policies, drafting regulations, supervising its implementation, as well as formulating management and service policies that encourage new technologies for cosmetics, drug and medical devices.

2. Standard Management

CNDA is obliged to draft cosmetic standards, formulate a cosmetic classification management system and supervise its implementation.

3. Registration Management

CNDA is responsible for formulating cosmetic, drug and medical device registration management system. It will also strictly conduct market entry review and approval.

4. Quality Control

CNDA is responsible for formulating cosmetic, drug and medical device quality control practices. 

5. Post-market Risk Management

CNDA will carry out monitoring, evaluation, rectifications and recalls associated with cosmetic adverse reactions, as well as undertake cosmetic safety emergency management.

6. Supervision and Inspection

CNDA is obliged to formulate inspection rules, penalize illegal activities in cosmetic registration and manufacturing.

7. Foreign Exchange and Cooperation

CNDA will participate in the formulation of international regulatory rules and standard.

CNDA function transformation:

1. Decrease processes that require administrative license. CNDA will gradually cancel administrative approval for imported non-special use cosmetics or change administrative approval to filing. Implement classified management on cosmetic new ingredients. Ingredients with high risk shall obtain administrative licenses, while ingredients with low risk only require filing certificates.

2. Strengthen post-market surveillance. Fully implement the inspection principle of “Double Randomization and One Disclosure” (Enterprises are randomly selected from the list of supervised enterprises, inspectors are randomly selected from the list of inspectors and inspection results shall be disclosed to the public) and method of “Internet plus Inspection".

3. Promote electronic review and approval.

4. Improve cosmetic review, examination, inspection and monitoring system. Promote traceability system construction and clarify enterprises' responsibility.

In addition, CNDA should coordinate with other ministries to optimize comprehensive supply chain management and supervision on cosmetics, drug and medical devices with major interactions summarized below:

1. State Drug Administration is responsible for formulating cosmetic, drug and medical devices’ regulatory systems, as well as approval, inspection and penalties for cosmetics research. Provincial drug administrations are responsible for approval, inspection and penalties for cosmetic manufacture. Administrations for market regulation at city and county level are responsible for inspection and penalty in cosmetic operation.
2. A coordination system should be set up between CNDA and Ministry of Public Security. Ministry of Public Security is responsible for cosmetic, drug and medical devices criminal cases' investigation. If CNDA uncovers illegal activities the case is then transferred.