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About Life Sciences Law

Lexis®+ Life Sciences is an online practical guidance product for contentious and non-contentious lawyers providing advice to and supporting the UK’s Life Sciences sector.

Research and development

Highly regulated, with strict compliance rules, work can be in-house or in collaboration with another entity. Guidance includes practice notes on UK and EU regime for clinical trials and various precedents.

Intellectual property

Patents and supplementary protection certificates are significant to many life sciences businesses. We have practice notes on pharmaceutical patents, biotechnology patents, IP protection for medical devices and more.

Medicinal products

This content includes guidance on marketing authorisations, orphan and paediatric medicines, pharmacovigilance, manufacturing, unlicensed and off-label medicines.

Medical devices

Covering key areas of medical devices regulation including classification, conformity assessments, clinical and performance evaluation as well as post-market surveillance.

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Associated legal terms

Accelerated assessment

Many countries offer a regulatory pathway that will expedite the evaluation of certain medicinal products so that they reach patients faster. In the EU, the accelerated assessment procedure reduces the timeframe for the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to review a marketing authorisation (MA) application from 210 to 150 evaluation days. Applications may be eligible for accelerated assessment if the CHMP decides the product is of major interest for public health and therapeutic innovation. In the UK, the Medicines and Healthcare Regulatory Agency (MHRA) offers a 150-day assessment timeline for all high-quality new MA applications in an effort to accelerate the availability of new medicines for patients in the UK. The MHRA evaluates the application for a UK, Great Britain (England, Wales and Scotland) or Northern Ireland MA and reaches its opinion on whether to approve the licensing of new medicines within 150 days of submission of a valid application. See also: marketing authorisation (MA).

Active pharmaceutical ingredient (API)

Also referred to as a ‘drug substance’, this term refers to any substance or mixture of substances intended to be the biologically active ingredient (or ‘active substance’) contained in a final medicinal product and intended to provide pharmacological activity or other direct effects. It is internationally defined as: ‘…any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.’ Medicinal products are usually composed of several components: the primary biologically active ingredient(s) which form the active pharmaceutical ingredient (API) plus other non-active ingredients known as ‘excipients’. The procedure for optimising and compositing this mixture of components, often producing ‘pharmaceutical intermediate’ byproducts as synthesising the API, and excipients into a final medicinal product is referred to as drug ‘formulation’. APIs are legally required to be registered with drug regulatory authorities (eg MHRA, FDA, EMA) and manufactured in compliance with good manufacturing practice (GMP) regulations and licensed facilities.

Medicinal Product

/mɪˈdɪsɪn(ə)l/ /ˈprɒdʌkt/

Any substance or combination - presented as having properties for treating or preventing disease in humans; or - which may be administered to humans either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
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