+91-98 455 710 46 | info@nckpharma.com

Pharma News

Keep updating your pharma knowledge
What is Biologic License Application
19 Oct 2015

What is Biologic License Application (BLA)?

Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. BLAThe Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product. A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product. Therefore, A BLA is a request for permission to market launch a innovator biologic product in US. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards.  Form 356h specifies the requirements for a BLA.

Executive Program in Biopharma Business Development and Strategic Management

KPE – C- 022 KPE’s Certificate Program in Biologic (Biotech & Biosimilar) Regulation & Strategic Management

Leave a Reply

The reCAPTCHA verification period has expired. Please reload the page.

Upskill Your Pharma Knowledge

Explore Next Gen Learning

Case Studies & Caselets | Simulation Based Learning | E-Lectures | Online Self Competency Assessments

Thank You for Subscription!