The Regulation on Effectiveness and Reliability Studies and Clinical Research of Cosmetic Products or Raw Materials (“Regulation”) has entered into effect. The Regulation was prepared by the Turkish Pharmaceuticals and Medical Devices Agency (“Agency”) and published in Official Gazette number 29481 on 20 September 2015. It outlines procedures and principles for conducting effectiveness studies regarding cosmetic products or their raw materials, as well as reliability studies and clinical research on volunteers. It also addresses protection of volunteer rights and working principles for the Cosmetic Clinical Research Ethical Board.
Significant provisions in the Regulation include:
- General principles for studies or research conducted on volunteers (Article 5). In particular, the Regulation states:
- If the study or research involves cosmetic products or raw materials, research must first be conducted in a non-human test environment.
- Reliability assessments must be conducted before studies and research into cosmetic products or raw materials can occur (Article 5(a)-(b)).
- Clinical research regarding cosmetic products or raw materials can only be conducted in places which (Article 9):
- Ensure the safety of research subjects and are suitable for conducting research in a healthy manner, as well as conduct follow-ups and emergency interventions, if necessary.
- Are one of the following:
- University health practice and research center.
- Authorized research-development center, affiliated to a university.
- Ministry of Health training and research hospital.
- Laboratory with personnel, equipment and laboratory facilities consistent with the quality of the research.
- Applications for studies and research can be made to the Agency by a supporter, contracted research institution assigned by the supporter or principal investigator. Certain applications require permission from the Ethical board and in these cases, studies and research can only begin after receiving Agency permission.
If the Agency declines a research or clinical study application, it will provide a justified decision to the applicant. The applicant receives a single opportunity to re-apply with the necessary application amendments, or object to the Agency’s decision (stating justifications). The Agency can reject the second research application if the amendments are not satisfactory, or the applicant’s objection is not admissible (Article 10).
- After producing and importing cosmetic products or their raw materials, the supporter, contracted research institution assigned by the supporter or the principal investigator are responsible for storage of cosmetic products or their raw materials (depending on which party made the application). This party is also responsible for distribution and delivery to the research center, as well as disposal (if required). Records must be kept regarding all these processes (Article 14).
- The Agency will conduct or commission an audit of the following places and entities regarding compliance with the Regulation and other relevant legislation, without being required to provide notice (Article 25):
- Centers where clinical research into cosmetic products or raw materials is occurring on volunteers.
- The supporter and contracted research institution.
- Manufacturing sites for the cosmetic products or raw materials which are being researched.
- Laboratories where research analysis occurs.
- Ethical boards.
- Where situations arise which are not specifically addressed by the Regulation, provisions of other relevant legislation will apply, along with the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine Convention for the Protection of Human Rights Dignity with Regarding The Application Of Biology and Medicine, Medical Deontology, Ordinance (Article 29).
Please see this link for full text of the Regulation (only available in Turkish).