Question & AnswerQ&A (FDA CIRCULAR NO. 2013-026)
Republic Act No. 3720, otherwise known as the Food, Drugs, and Devices, and Cosmetics Act, as amended, and Republic Act No. 9711, the FDA Act of 2009 declare this policy.
To formally adopt the ICH Harmonised Tripartite Guideline, Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products Q5C as a regulatory requirement for stability studies of biotechnological products.
All manufacturers, traders, and distributors of biotechnological/biological products including vaccines are covered under this Circular.
A biological product means any attenuated or inactivated virus or bacteria, subcomponents attached to adjuvants, toxoids, hyperimmune serum, and analogous products used for diagnosis, prevention, treatment or cure of diseases, obtained or derived from living matter like animals, plants, or microorganisms.
Biotechnological products are defined as products prepared with genetic engineering or other newer biotechnological techniques. All biotechnological products fall within the definition of biological products.
No, antibiotics and substances that are of low molecular weight that can be isolated as pure substances, such as purified steroids and alkaloids, are not included.
They must follow the adopted ICH Harmonised Tripartite Guideline, Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products Q5C.
Yes, all supplements and revisions related to the adopted ICH guideline shall be automatically adopted.
The Circular took effect on November 11, 2013.
No, they apply only to incoming applications. Pending applications and their compliances are not covered by this Circular.
The remainder of the provisions of the Circular shall not be affected according to the separability clause.
The adopted ICH guideline shall be made available on the FDA website.