USFDA OTC Drug Registration Guidelines for Certified Manufacturers and Approved Plants
What is OTC Drug Product in USFDA? Over-the-counter or OTC drugs are drug products that are considered safe and effective by the FDA and yet can be purchased without a prescription. Now, there are more than 300,000 OTC products in 100 different therapeutic categories. Some examples of OTC drug products, such as acne creams, dry […]
Unlocking TGA Compliance: A Roadmap to Drug and Site Registration in Australia
Introductory The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health and Aged Care, the TGA regulates the quality, supply and advertising of medicines, pathology devices, medical devices, blood products and most other therapeutics. Any items that claim to have a therapeutic effect, are involved in the […]
Understanding the Role of MHRA in Medicines Regulation
Introduction The Medicines and Healthcare Products Regulatory Agency (MHRA) is the government agency that regulates pharmaceuticals, blood establishments, advanced therapy medical products, and medical devices in the United Kingdom. The agency formed following the merger in 2003 of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA), then in 2013 with the National […]
INVIMA Regulations in Colombia’s Pharmaceutical Landscape
Understanding INVIMA’s Role In the dynamic landscape of pharmaceuticals, ensuring the safety, efficacy, and quality of drugs is paramount. For pharmaceutical manufacturers and exporters, obtaining certification and approval from regulatory bodies like the National Institute of Food and Drug Surveillance (INVIMA) in Colombia is crucial. INVIMA Colombia, founded in 1994 serves as Colombia’s primary regulatory […]
COFEPRIS: Ensuring Safety and Quality in Mexico’s Health Products
What is the COFEPRIS? COFEPRIS, the Federal Commission for the Protection against Sanitary Risks, is a pivotal regulatory body in Mexico, ensures the safety and quality of health products. Established in 2001 as mandated by Article 17 Bis of the General Law of Health and Article 4 of the Constitution, COFEPRIS is responsible for certifying […]
Unlocking Regulatory Insights: Navigating Health Product Approval with ANVISA Brazil
What is ANVISA? ANVISA was established in 1999 under Law No. 9.782 with the primary objective of promoting and protecting public health by regulating products and services subject to health surveillance. In Brazil, the registration of drugs and manufacturing sites with the National Health Surveillance Agency, ANVISA (Agência Nacional de Vigilância Sanitária), is a crucial […]
