Regulatory Services in Turkey
Turkey
The Turkish Medicines and Medical Devices Agency (TITCK) of the Ministry of Health is the authoritative body that is responsible for the regulation, inspection, and control of medicinal products and medical devices. The “Registration Regulation of Human Medicinal Products” dictates the registration and review procedures for medicinal products and devices intended for human use. Similar to most European and US procedures, the registration of a pharmaceutical product with Turkey’s Ministry of Health requires a license application and a GMP certificate. Regulatory authorities are also required to thoroughly inspect manufacturing sites in the interest of patient and employee safety to determine if the manufacturing processes are safe and repeatable. Hence, a GMP certificate is an integral component of drug manufacturing process. These guidelines set by the Turkish authorities are in line with international standards, with the goal to provide safe and efficient access to medicinal products. However, obtaining market authorizations for medicinal products takes significantly longer compared to other agencies such as the FDA or EMA due to various reasons including company response time and committee assessment timeline. Additionally, as Turkey is not a member of the Pharmaceutical Inspection Convention and Cooperation Scheme, the Turkish authority must negotiate with other countries for mutual agreement and recognition of each other’s certificates. This contributes towards delayed approval processes. Changes in Registration Regulations further prolong the approval process timeline which has shown to increase the medicinal registration timeline by more than 50%.
As a leading global contender, DDReg’s regulatory services in Turkey provides on-going support and development of the customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings, and market authorizations.
DDReg Services include:
- Regulatory Strategies and Expert Views
- Regulatory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- API/DMF
- ICSR Processing and Submission
- Risk Management
- Aggregate Reports
- Signal Management