Important Development in Cosmetic Product Regulations in Turkey: New Draft Regulation on Studies to be Conducted on Humans
Important Development in Cosmetic Product Regulations in Turkey: New Draft Regulation on Studies to be Conducted on Humans
The Turkish Medicines and Medical Devices Agency (TİTCK) has submitted a new draft regulation for public consultation regarding studies to be conducted on humans using cosmetic products. This new regulation aims to ensure the safe, transparent, and ethical conduct of efficacy and safety studies on volunteers for cosmetic products. The draft is open for comments until November 22, 2024, and feedback can be submitted to the Department of Cosmetic Products via the “Draft Feedback Form.”
Purpose and Scope of the Draft Regulation
The draft regulation aims to set scientific and ethical standards for studies conducted on volunteers with cosmetic products, protect the rights of volunteers, and regulate the recording and reporting processes for such studies. Following the amendments to Article 10 of the Basic Law on Health Services (Law No. 3359), it became necessary to restructure the framework for studies on volunteers with cosmetic products. Consequently, the previous regulation from 2015 was repealed and replaced with a more comprehensive and up-to-date version.
This draft regulation defines the procedures for conducting efficacy and compatibility studies, scientific research, and consumer perception tests on volunteers using cosmetic products. Additionally, it introduces ethical rules and scientific standards for those conducting these studies, ensuring the protection of volunteer rights.
Key Points and Regulations in the Draft
Some key points and notable regulations in the draft include:
- Efficacy and Compatibility Studies: These studies, which aim to verify the efficacy claims of cosmetic products, involve various methods like consumer perception tests or instrumental measurements. Compatibility studies, on the other hand, assess the product’s compatibility with tissues, such as skin.
- Consumer Perception Tests: These tests aim to measure consumer observations or feelings about the effects of the products. Consumer perception tests can be conducted without ethical committee approval for products already on the market, while approval is required for unmarketed products.
- Scientific Studies and Ethical Standards: Special regulations have been implemented for scientific research using cosmetic products, particularly for research conducted as part of academic projects or thesis studies. The ethical committee approval is mandatory for these studies, ensuring compliance with efficacy and safety standards. This regulation also defines the responsibilities of the Cosmetic Products Ethics Committees, emphasizing the protection of volunteer rights.
- Standards and Approval Processes: The draft also outlines specific conditions under which studies can be conducted, as well as standards that must be met by individuals and organizations conducting them. The regulation mandates that institutions conducting studies must obtain the necessary permits. Additionally, the locations where studies are conducted must meet requirements for volunteer safety, and must have adequate staff and equipment.
Necessity and Importance for the Industry
This draft regulation is highly significant for ensuring ethical standards in studies on volunteers within the cosmetics industry. Based on the amendments to Law No. 3359 dated May 7, 1987, it became essential to create a safer framework for studies involving volunteers with cosmetic products. The new regulation enables scientific research to be conducted on a secure and ethical basis while prioritizing the health and safety of volunteers.
Examining the effects of cosmetic products on volunteers is essential for product safety. However, these studies should prioritize volunteer rights and safety. The draft regulation prepared by TİTCK increases the credibility of the industry by ensuring volunteer rights and standardizing ethical research processes.
Once implemented, the regulation will bring clarity to ethical rules for all studies involving volunteers in the cosmetics industry. Public feedback on the draft regulation will contribute to making it more comprehensive and will reinforce ethical practices within the sector.