Healthcare products include over-the-counter (OTC) medicines, some cosmetic products, herbal medicines, and nutraceuticals such as vitamins and supplements. The sector also includes many household brands that are readily available in supermarkets and pharmacies, but they are subject to the same regulatory and quality control measures as other pharmaceutical products.
OTC medicines typically contain well-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’s 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.
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 encourages companies to develop own-brand and generic equivalents of blockbuster products at lower prices. As with pharmaceuticals, the need for greater understanding of active ingredients used to streamline application maintenance of marketing authorisations and 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.
How Woodley BioReg supports the Healthcare sector
WBR 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.