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Turkey-TITCK (Türkiye İlaçveTıbbiCihazKurumu)- Approval Processes for Generic Drug

Regulatory Authority:

Turkish Medicines and Medical Devices Agency (TMMDA)

Link for Regulatory Authority:

https://www.titck.gov.tr/iletisim

Local Authorised:

Yes

Classification:

Novelty, Therapeutic Category, and Risk.

Registration Timeline:

30 to 60 months

Registration Fee:

  • Full MMA: TRY 100,000 – TRY 500,000 (approx. USD 5,000 – USD 25,000)
  • Conditional MMA: TRY 50,000 – TRY 250,000 (approx. USD 2,500 – USD 12,500)
  • Import Permit for Clinical Trials: TRY 10,000 – TRY 50,000 (approx. USD 500 – USD 2,500)

License Validity:

5 Years

1.Application Form:

Complete and submit the official application form provided by the regulatory authority.

2.Product Information:

Detailed information about the generic drug, including its composition, manufacturing process, and specifications.

3.Quality Control and Manufacturing Information:

Documents related to Good Manufacturing Practices (GMP) compliance.

Certificates of Analysis (CoA) for both the active pharmaceutical ingredient (API) at the finished product.

Details about the manufacturing process and controls.

4.Bioequivalence Data:

Bioequivalence study results demonstrating the similarity of the generic drug to the reference (innovator) drug.

5.Stability Data:

Stability studies providing information on the drug’s stability under various conditions.

6.Clinical Data (if required):

Clinical trial data, if necessary, depending on the specific requirements for the type of drug.

7.Pharmacovigilance Data:

Information on pharmacovigilance, including safety monitoring plans and risk management plans.

8.Packaging Information:

Details on the packaging of the generic drug, including labelling and package insert.

9.Authorization from Reference Country (if applicable):

If the generic drug is authorized in a reference country, relevant documentation from that country may be required.

10.Legal and Regulatory Documents:

A power of attorney if the application is made by a representative.

A copy of the generic drug’s license in the country of origin, if available.

11.Fees and Application Payment:

Payment of the required fees for the application process.

12.Risk Management Plan (if required):

Submission of a risk management plan for certain drugs may be necessary.