Regulatory agencies aim to protect human health in global pharma. We will discuss ten reputed regulatory bodies of the global pharma industry here.
Regulatory agencies are the governing bodies aiming to protect human health in the global pharmaceutical industry. Therefore, they play a crucial role in meeting the requirements of legal procedures related to drug development. In addition, regulatory agencies ensure healthcare products’ safety, efficacy, and quality, and compliance with statutory duties. Further, the agencies periodically check the production sites for new and previously established products and procedures.
With the growing presence of pharmaceutical companies in more than 100 countries, most countries have established pharmaceutical legislation and regulatory requirements. Regulatory bodies issue various guidelines on the drug development process, licensing, manufacturing, marketing, patenting, registrations, quality control, good laboratory practices, handling of OTC drugs, packaging, labeling, storage, etc.
Furthermore, the pharmaceutical industry must comply with national regulations and international regulations if their product is implied for the international market. They have the authority to impose heavy penalties and product recalls in case of non-compliance. A list of Globally identified websites of medicines regulatory authorities is provided by the WHO. Out of these, we will discuss ten reputed regulatory bodies of the global pharma industry here.
The Food and Drug Administration (FDA) is responsible for protecting public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products. FDA is also responsible for advancing public health by helping to speed innovations that make medicines safer, more effective, and more affordable.
The Medicines & Healthcare products Regulatory Agency (MHRA) is the government agency responsible for ensuring the proper use of medicine and medical devices. The MHRA is an executive agency of the Department of Health.
The Brazilian Health Regulatory Agency (Anvisa) is an autarchy linked to the Ministry of Health, part of the Brazilian National Health System (SUS) as the coordinator of the Brazilian Health Regulatory System (SNVS), present throughout the national territory.
Anvisa’s role is to promote the protection of the population’s health by executing sanitary control of the production, marketing, and use of products and services subject to health regulation, including related environments, processes, ingredients, and technologies, as well as the control in ports, airports, and borders.
The Therapeutic Goods Administration (TGA) is the regulatory authority for the Australian pharmaceutical industry. The TGA oversees and regulates numerous therapeutic goods, including prescription medicines, vaccines, and medical devices. The site contains information specific to consumers, health professionals, and industry manufacturers. It also lists recent pharmaceutical recalls and alerts.
The Central Drugs Standard Control Organization in India sets standards and regulatory measures for medications. Further, the organization guides on health issues and medicines. They also regulate the standards of imported drugs and clinical research in India. Various regulatory documents and forms are available to download for free in PDF from the website.
WHO (World Health Organization) is the United Nations specialized agency for health. It is responsible for providing leadership on global health matters shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends. In addition, it is the United Nations agency that connects nations, partners, and people to promote health, keep the world safe, and serve the vulnerable. So everyone can attain the highest level of health.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss pharma-related scientific and technical aspects and develop guidelines. Since its inception in 1990, ICH has gradually evolved to respond to increasingly global developments in the pharmaceutical sector.
The European Medicines Agency (EMA) protects and promotes public health by evaluating medicines. The EMA provides recommendations on the quality and safety of medicines. In addition, they apply evaluation procedures to help bring new medicines to the European Union.
9. HEALTH CANADA
Health Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible and works to reduce health risks. They focus on product safety, environmental and workplace health, food and nutrition, health and science research, drugs and health products, etc.
10. Egyptian Drug Authority (EDA)
In 2008, the Ministry of Health established the Egyptian Drug Authority (EDA) to have an independent regulatory body responsible for all pharmaceutical-related activities. It is similar to the function of India’s FDA in the United States. This establishment was seen as a landmark restructuring in the Egyptian pharmaceutical industry. There had yet to be an independent and organized body to manage pharmaceutical regulatory affairs beforehand.
As a Global Pharma, NEWEDGE Overseas exports a wide range of products to more than 40 countries. Every product that passes through the NEWEDGE supply chain be it raw material or an end-product adheres to all requisite regulatory compliances making it safe for consumption. In addition, our regulatory audits ensure that the products we offer and the processes we employ accurately comply with the regulatory dictates of specific countries.