Pharmaceutical Organisations You Must Know

By: Donagh Fitzgerald B.Prod Eng and Claire Wilson BSc. Last Updated: Jan 2022

You would be amazed at the number of people we have come across over the years looking for a position in the pharmaceutical manufacturing sector but who didn’t know what the (FDA) precisely stood for? (And no, it’s not the “Federal Drug Agency”!)

Anyway, here is a shortlist of some of the organizations you should be familiar with. Take some time to go through each of their websites and take notes.

Also, if you are interested in a new career in pharma or want to upskill for a promotion, check out our pharmaceutical courses.

The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services and is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation, cosmetics, emitting devices (ERED), and veterinary products.

The European Medicines Agency (EMA) is the decentralised agency of the European Union (EU), set up in 1995. They are tasked with scientifically evaluating, supervising and monitoring the safety of pharmaceutical products produced for use within the EU. For companies to gain a marketing license within the EU, the EMA must first scientifically review the application – a marketing license is essential to a company wanting to market their product in Europe. The EMA also acts as a central point for pharmacovigilance, the safety monitoring of medicines, utilising the network of European monitoring agencies and tracking the safety of medicinal products. The EMA can also work in direct response to concerns raised about a product, to reevaluate the safety and risk-benefit balance of its use.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was formed in 1990 with the unique intention of bringing together the pharmaceutical industry and regulatory bodies to drug regulation from a scientific and technical perspective. As the industry became more globalised, the ICH has adapted to promote rationalisations and harmonisation of practices to ensure that pharmaceutical products are high quality, effective and safe, and that registration of these products is efficient across the world.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any Authority having a comparable GMP inspection system. PIC/S presently comprises 54 Participating Authorities coming from all over the world (Europe, Africa, America, Asia and Australasia).

The Medicines & Healthcare products Regulatory Agency (MHRA) is an executive agency of the UK’s Department of Health that regulates all medicines, medical devices and blood components for transfusion across the UK. They work to ensure that products for use in the UK meet quality and efficacy standards, that supply chains are safe and secure, that the UK public and healthcare professionals are well informed about the risks and benefits of medicines and medical devices. They work closely with similar agencies in other countries to try to promote standardisation and input into national and international regulatory frameworks. Finally, they do also work to support innovation and research and development that benefits public health.

The Health Products Regulatory Authority (HPRA) is the Irish state agency that regulates medical devices, medicines and other health products. They evaluate and regulate all such products produced in Ireland, whether they are to be used within the country or exported. Their main duties include issuing licensing to companies to allow manufacturing, monitoring these activities and responding to any issues that might arise. In addition, they also produce quality and safety information as guidance for use of health related products. The agency was previously known as the Irish Medicines Board.

The World Health Organization (WHO) is a specialized agency of the United Nations (UN) that is concerned with international public health. It was established on 7 April 1948, with its headquarters in Geneva, Switzerland. WHO is a member of the United Nations Development Group.


Industry Bodies

Pharmachemical Ireland is the leading industry body representing the manufacturing of pharmaceuticals, biopharmaceuticals and chemicals in Ireland. It works by bringing together industry, the research community, the government and the public to promote Ireland as a location of excellence for pharmaceutical, biopharmaceutical and chemical supply manufacturing and development.