NAFDAC Product registration and Approval: Essential Steps for Manufacturers, Suppliers, and Exporters
What is NAFDAC? The National Agency for Food and Drug Administration and Control (NAFDAC) was established by Decree No. 15 of 1993 as amended by Decree No. 19 of 1999 and now the National Agency for Food and Drug Administration and Control Act Cap N1 Laws of the Federation of Nigeria (LFN) 2004 to regulate […]
Unlocking the Path for FDA Philippines Approval for Products & Plants Registration
What is FDA Philippines? The Food and Drug Administration (FDA) of the Philippines, established under Republic Act No. 3720 and later amended by Republic Act No. 9711, is responsible for ensuring the safety, efficacy, and quality of health products. This includes regulating food, drugs, cosmetics, medical devices, vaccines, and other health-related products such as pesticides […]
PPB Kenya Registration: Essential Guidelines for Sites and Products
Describe PPB Kenya The Pharmacy and Poisons Board of Kenya is referred to as PPB Kenya. It is the regulatory organization in Kenya that oversees the registration, management, and control of medical devices, pharmaceuticals, and healthcare providers. Before these goods may be sold and utilized in the nation, the PPB makes sure they fulfil acceptable […]
Navigating the EU GMP Certification & Product Approval Process
EU GMP: What is it? EU GMP is Good Manufacturing Practices, promulgated by European Medicines Agency (EMA). EU GMP is the guidelines that pharma manufacturers must meet in their medicine manufacturing process. What is EMA? EMA is European Medicines Agency, established in 1995. The head office is in Amsterdam, the Netherlands. EMA is an agency […]
DIGEMID’S Approval Process: A Guide for Manufacturers and Exporters
Introductory DIGEMID, the General Directorate of Medicines, Supplies, and Drugs in Peru, is a vital regulatory authority established on April 18, 1990, under the Ministry of Health. Its primary mission is to ensure that the Peruvian population has access to safe, effective, and high-quality medicines and health products. This agency plays a crucial role in […]
2030 Vision of Effervescent Tablets Manufacturer in India: The Bubbles, Innovation Era start here
Effervescent tablets have gained significant popularity in the pharmaceutical and dietary supplement markets due to their unique properties and benefits. As a leading effervescent tablet manufacturer in India, it is essential to understand the product’s composition, advantages, and market demand to effectively target potential customers and improve online visibility. *For more details about market size click […]
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 […]
