Turkey has been on a mission to update and clarify its regulatory guidelines in an effort to improve and streamline processes for companies and regulators.
In mid-September 2021, the Turkish Medicines and Medical Devices Agency of the Ministry of Health (MoH) released its updated guidelines on biosimilar products, providing more detailed information for companies looking to bring their products to market in Turkey. The previous version, which was issued in 2008, provided sparse details for companies, and largely referred to the European Medicines Agency (EMA) guidelines. However, it should be noted that the new guidelines don’t offer the detailed product-specific guidelines on biosimilars that the EMA has published.
A side-by-side comparison between the 2008 and the 2021 guidances show significantly more detail in the latest iteration, particularly the section on “General Principles”, which lays out implementation of the biosimilar approach.
While the latest guideline does not directly reference EMA biosimilar guidelines, as the previous one had done, Article 25 of the new guideline recommended that other national and international guidelines addressing quality, non-clinical and clinical issues must also be taken into account during the development of biosimilar products.
For the first time in Turkey, the guidance gives biosimilars companies detailed information on the product development and documentation process required, for example, clearly defining requirements around the quality target product profile (QTPP) and molecular properties, as well as the types of studies required during the development process.
The latest guidance also lists more detailed information about non-clinical trials, clinical trials and pharmacovigilance activities of biosimilars, and, like the EMA guidelines on biosimilars, it also recommends a step-wise approach to developing a biosimilar.
The depth of information and detail makes it much easier for companies seeking to register their products in Turkey and, when properly followed, should speed up the registration process.
In the past, companies would have to prepare their regulatory filing based on the general regulation for submission, then cross-reference more specific biosimilar requirements with the EMA guidelines. This was both time-consuming and complex for the companies since previously the MoH had not issued a detailed document for biosimilar registration files.
Having clearer guidance should help companies to develop a complete regulatory submission in keeping with MoH requirements and proceed to the next stage – and hopefully market approval – more rapidly.
It is also important to note that the MoH conducted a thorough consultative period and that the latest guidance has been developed in consultation with the industry, with back-and-forth comments from companies contributing to the final outcome.
For companies seeking to bring their biosimilar product to the Turkish market, ProductLife Group’s team of regulatory experts in Turkey have carefully evaluated the latest guidance and can support any product submission. Our team has extensive knowledge of the marketplace, deep regulatory experience, and a clear understanding of what the health authorities expect. Contact us to find out how we can help you.