GxP is an abbreviation for generic good practice, which refers to the series of laws, regulations, and guidance that govern various areas of the research, development, testing, manufacturing, and distribution of medicines. GxP rules and guidelines ensure that all aspects of the medicines development process are conducted according to the best methods for safety, efficacy, and quality.
Medicines regulation is the basis for ensuring that only medicines of a high quality are marketed. In Europe, the European Commission proposes high-level legislation in the form of regulations and directives. The European Medicines Agency (EMA) coordinates the development of new and revised EU scientific guidelines in working groups/parties.
A medicine can be marketed in the European Union (EU) until the company has obtained a Marketing Authorisation (MA) for that medicine from the relevant regulatory authority. MAs are granted for medicines that are proved to be safe, effective and of high quality.
A Paediatric Investigation Plan (PIP) must be submitted in order to support a medicine’s authorisation for use in children. The PIP undergoes a review process and ensures that paediatric development happens at the right time in the medicines development process. In special cases, the PIP can be waived.
This article explores patient involvement in scientific regulatory committees in the EU, specifically in the activities of the European Medicines Association (EMA).
The European Pharmacopoeia comprises quality standards for active pharmaceutical substances, as well as analytical methods for the identification of the substance and the evaluation of its quality and quantitative strength.
Before a medicinal product can be marketed and sold, a marketing authorisation must be obtained from the relevent National Competent Authorities. The marketing authorisation application process can take one of two paths – the decentralised procedure, or the centralised procedure. In some cases in Europe, the centralised procedure is mandatory.
Off-label use of a medicine is the use of an authorised medicine by a healthcare professional to treat a patient in a way not covered by the Marketing Authorisation (MA) and detailed in the Summary of Product Characteristics (SmPC) of the medicine.
Information on medicinal products is provided to patients and healthcare providers in different, carefully regulated ways – including package labelling, package leaflets, and the Summary of Product Characteristics.
The EMA Committee for Advanced Therapies (CAT) reviews the quality, safety, and efficacy of Advanced-Therapy Medicinal Products (ATMPs).