Adoption of the ICH Harmonised Tripartite Guideline, Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products Q5C

 I. Background

Republic Act No. 3720, otherwise known as the "Food, Drugs, and Devices, and Cosmetics Act", as amended, and further strengthened by Republic Act No. 9711, otherwise known as the "FDA Act of 2009", declare it a policy of the State to ensure the safety, efficacy and quality of drugs, including biotechnological/biological products and vaccines. In line with this, Administrative Order No. 47-a, series of 2001, "Rules and Regulations on the Registration, including Approval and Conduct of Clinical Trials, and Lot or Batch Release Certification of Vaccines and Biologic Products" was promulgated for the regulation of such products.

However, with the recent advances in the regulatory science, the current guidance for the conduct of stability studies for these products prove to be insufficient and not at par with international  standards, specifically, the International Conference on Harmonisation (ICH) Q5C. Thus, in order to ensure the safety, efficacy, and quality of such products, and to align with international standards, this Circular is hereby issued to adopt the aforementioned guideline document.


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