Healthcare and over-the-counter medicines

What does the Healthcare and over-the-counter medicines industry include?

Healthcare products include over-the-counter (OTC) medicines, some cosmetic products, herbal medicines, and nutraceuticals such as vitamins and supplements. Although the sector also includes many household brands that are readily available in supermarkets and pharmacies, it is important to note that they are subject to the same regulatory and quality control measures as other pharmaceutical products.

OTC medicines generally contain long established active pharmaceutical ingredients with well-observed effects over a long period of time. Ibuprofen is a typical example of a molecule that was originally available as prescription-only but is now a common over-the-counter product. It is important to note that healthcare products and pharmaceuticals are subject to the same legislation, in terms of requiring a Marketing Authorisation, Product Licence maintenance, and manufacture under cGMP.

Healthcare legislation

The global governing bodies (Food and Drug Administration (FDA) in the US, the Medicine and Healthcare Product Regulatory Agency (MHRA) in the UK and the European Medicines Agency (EMA) for over-the-counter medicines and pharmaceuticals are the same. In Europe, herbal medicines are required to prove safety, efficacy, and quality of the product through a Marketing Authorisation or a traditional herbal registration (THR) which also stipulates traditional use. The regulatory and registration requirements in the rest of the world are tailored on individual markets, based on their domestic legal frameworks.

Key trends within the healthcare industry

Increased education, advertising and information aimed at consumers, higher disposable incomes in developing nations, reduced budgets for national health services, and the promotion of self- management of minor ailments, have created demand and growth in the OTC sector. This in turn has encouraged companies to develop own-brand and generic equivalents of blockbuster products at lower prices. As with pharmaceuticals, the need for greater understanding of the active ingredients that are used to streamline application maintenance of Marketing Authorisations as well as an increasing need for regulated packaging and management of risks, such as adverse reactions, continue to play a major role in this sector of the industry.

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How Woodley BioReg supports the healthcare sector

Woodley BioReg supports the healthcare industry by ensuring all clients, from brand leaders to small manufacturers receive bespoke advice on regulatory and quality issues, provided in a flexible resourcing model to suit the client’s needs. Our extensive knowledge of API and finished products ensures our advice to clients is designed to expedite the registration, approval, and maintenance of OTC dossiers.