Common Technical Documents

Turkey updates CTD guide and variation documents

The Turkish Ministry of Health (MoH) has published an updated common technical document (CTD) guide and variation guides, effective from 30 December 2005^1,2. The MoH has stated that all applications must be prepared in accordance with the new rules or they will not be evaluated.

The updated CTD presentation procedure is valid for all types of marketing licence applications, whether complete or abbreviated, and is valid for all product types (new chemical entities, radiopharmaceuticals, vaccines, herbal medicinal products, etc)¹. Within these product groups, for products being licensed for the first time, a cross-reference may be given in the Notice to Applicants (NTA) format. The NTA has been designed to comply with the obligations arising out of Annex I of the Turkish Human Pharmaceuticals Licensing Regulation.

Applicants are required to confirm with the MoH whether the CTD format is applicable for a particular product or not. The files of medical products already licensed are not required to be reformatted according to the new CTD format.

The CTD procedure follows guidance from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) on the compilation of files for marketing licence applications². In compiling the file, applicants must comply with the EU guidelines relating to quality, safety and efficacy of human pharmaceuticals and medical products in Volumes 3A, 3B and 3C of the Rules Governing Medicinal Products in the European Union and with other guidelines relating to quality, safety and efficacy of pharmaceuticals/medical products published by the European Commission³.

MELEK BOSTANC? ÖNOL

References

1. Turkish Ministry of Health, www.saglik.gov.tr

2. European Commission guidance documents on medicinal products for human use, http://pharmacos.eudra.org/F2/eudralex/vol-3/home.htm

3. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), www.ich.org