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
Reliability assessments must be conducted before studies and
research into cosmetic products or raw materials can occur (Article
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
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).
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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