Healthcare & Life Sciences Newsletter – July 2024

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published the Announcement on Type-1 Biocidal Products. The TİTCK also amended the Guideline on Reliance Practices in Clinical Trial Applications, the Guideline on the Applications for GMP Inspections of Overseas Manufacturing Facilities, and the Guideline on Cosmetic Products and Borderline Products.

Guideline on Reliance Practices in Clinical Trial Applications

On 5 June 2024, the TİTCK updated the Guideline on Reliance Practices in Clinical Trial Applications. The main amendments introduced by the Guideline are as follows:

— The TİTCK will not conduct GMP inspections (unless a violation of the legislation is determined) if the good clinical practices (GCP) inspections conducted by the International Council for Harmonization (ICH) founding member (US Food and Drug Administration (US FDA), European Medicines Agency (EMA), Japan Pharmaceuticals and Medical Devices Agency (PMDA)) or permanent member authorities (Swiss National Pharmaceutical Authority (Swissmedic) and Canadian National Pharmaceutical Authority (Health Canada)), Australian Therapeutic Goods Administration (TGA) or the UK Medicines and Healthcare Products Regulatory Agency (MHRA) (collectively, the “Competent Authorities”) are submitted, and the inspection reports indicate that the inspected centers/trials or trial data comply with GCP. However, if reports on GCP inspections conducted by other health authorities other than Competent Authorities are submitted, the TİTCK shall conduct GCP inspections in accordance with the relevant guideline.

— During clinical trial applications, a research product file (RPF) prepared in accordance with the relevant guidelines published by the TİTCK must be submitted. If the research product does not have a marketing authorization in Türkiye but has been granted a marketing authorization by the Competent Authorities, and the information related to the marketing authorization has not been changed, the submission of the RPF will not be required. Additionally, if the changes have been made to the information related to the marketing authorization, it will be sufficient to submit the relevant sections of the RPF, depending on the degree of change made in line with the issues in the quality guidelines. ­ If the research product has not been granted a marketing authorization by the TİTCK or Competent Authorities, the RPF must be submitted.

— The manufacturing site authorization certificate, or Good Manufacturing Practices (GMP) certificate, must be submitted in the clinical trial application file. In this regard, it will be sufficient to submit the information or document accepted by the TİTCK showing that the manufacturing site(s)/facility(s), where serial release, serial analysis control/quality control, external packaging and labeling manufacturing activities are carried out, manufacture in accordance with internationally accepted Good Manufacturing Practices.

— Although auxiliary pharmaceuticals must have a marketing authorization in Türkiye, the TİTCK can accept the use of products that have been granted marketing authorization by the Competent Authorities and that are used within the framework of the information based on the marketing authorization as auxiliary pharmaceuticals, if reasonable grounds are provided.

The Guideline is available here (in Turkish).

Guideline on the Applications for GMP Inspections of Overseas Manufacturing Facilities

On 7 June 2024, the TİTCK updated the Guideline on the Applications for GMP Inspections of Overseas Manufacturing Facilities. The main amendments introduced by the Guideline are as follows:

— Regarding homeopathic stock-manufacturing facilities of homeopathic pharmaceuticals, an application must be made within the scope of the Guideline for Good Manufacturing Practices (GMP) inspection of the manufacturing facilities of homeopathic stocks, falling under the scope of nosod and sarkod.

— Regarding the semi-finished, product-manufacturing facilities of conventional products, if the relevant facilities are located in countries other than Australia, the UK or founding members of the International Council for Harmonization (ICH) (USA, EU member states and Japan) or permanent (Canada and Switzerland) member states, and do not have a current GMP Certificate issued by the above-mentioned authorities, or if the products subject to the application do not have a European Pharmacopoeia Conformity (CEP) certificate, an application must also be made within the scope of the Guideline for the GMP inspection of the manufacturing sites of the relevant products.

— Depending on whether the manufacturing facility has been previously inspected by the TİTCK or not, applications can be made for the following types of documents for the belowmentioned manufacturing facilities: “Application for Inspection Evaluation on File for Each Product Based on Foreign GMP License” or “Application for Inspection Evaluation on File for Each Product Based on GMP License”:

— If the manufacturing site for the manufacturing activities of all product groups, except for the active substance manufacturing of biological and biotechnological products, operates in a country where there is a Pharmaceutical Inspection Cooperation Convention (PIC/S) member authority, the GMP certificate is requested by the same or a different company for the products manufactured / to be manufactured in a building different from the building where the products previously inspected on-site by the TİTCK were produced.

— Requesting a GMP certificate for a co-marketing product with the same/different dosage, manufactured at the same manufacturing site, using the same equipment, and having the same formulation as a product that has been previously inspected and received GMP approval.

The Guideline is available here (in Turkish).

Announcement on Type-1 Biocidal Products

On 10 June 2024, the TİTCK published the Announcement on Type1 Biocidal Products. The main developments introduced by the Announcement are as follows:

— An application for marketing authorization must be submitted by 1 January 2027 for biocidal products with statements such as “wound contour”, “preoperative area preparation”, “disinfection before injection”, etc. on the label. Products for which a marketing authorization application has been made and notified to the Cosmetic Products Department can be placed on the market until the expiry date.

— If the products that have been granted marketing authorization under Type-1 biocidal products are to continue to be placed on the market as biocidal products, a label registration application must be made by 1 January 2027 by removing the medical purpose statements on the labels. Products for which a label registration application has been made can be placed on the market in their current form until the end of their expiry date.

— The marketing authorization of biocidal products for which a label registration application has not been made by removing medicinal statements, or for which marketing authorization for pharmaceuticals has not been applied for by 1 January 2027, shall be revoked.

The Announcement is available here (in Turkish).

Guideline on Cosmetic Products and Borderline Products

On 14 June 2024, the TİTCK updated the Guideline on Cosmetic Products and Borderline Products. The main amendments introduced by the Guideline are as follows:

— The determination regarding the nature of products that are not cosmetics, but can be used as a means to deliver cosmetic ingredients/mixtures to the skin of the humans to clean, fragrance, keep in good condition, change the appearance or protect, shall be made by evaluating all the characteristics of the product (such as presentation, content, effect and purpose) together.

— In the assessment of the boundary between cosmetic products and pharmaceuticals/ medical devices, for a product to be deemed as a cosmetic product, the following points shall be considered due to the presentation of the product:

— It must not have a purpose to treat or prevent any disease, to diagnose, or to correct, regulate or modify a physiological function.

— It must not claim or imply that it restores, corrects or alters physiological functions as a result of pharmacological, immunological or metabolic effects.

— It must not refer to the effect of a pharmaceutical.

— It must not include a health declaration.

The Guideline is available here (in Turkish).

Conclusion

The TİTCK continues to provide guidance for companies working in the healthcare industry. Companies must carefully review the TİTCK’s announcements and take the necessary actions to ensure compliance.