Medicines are highly regulated and the Medicines and Healthcare Products Regulatory Agency (MHRA) issues a ‘marketing authorisation’ for every medicine.
The marketing authorisation governs not only what the medicine is for and how it should be used, but also the details of the formulation, storage requirements and shelf life, so that the medicine that reaches patients works and is of the same high quality every time.
To learn more about the work of the MHRA, visit the Licensing of medicines section of the MHRA website.
The MHRA also issues ‘manufacturing authorisations’ which entitle a company to manufacture medicines in the UK. Companies need to demonstrate that they comply with good manufacturing practice and pass regular inspections of the manufacturing site. To find out more about this, visit the MHRA website.
The ABPI works through its Pharmaceutical Quality Expert Network to monitor regulatory activity on these topics and participate in the development of legislation at both national and European levels. The Network also facilitates the exchange between members of good practice in these important areas.
Good environmental health and safety performance is a major consideration in all aspects of pharmaceutical industry activity.
Through the Environmental Health and Safety Network, we monitor regulatory activity on these topics and participate actively in the development of legislation at both national and European levels, as well as facilitating the sharing of good practice amongst member companies.
Delegated Regulation to the Falsified Medicines Directive (FMD) 2011/62/EU, published on the 9 February 2016, will come in to force by February 2019. The new regulation will require manufacturers to place safety features on all medicines and contribute financially to the establishment of an IT verification system that will allow the assessment of the authenticity of a medicine at the time of supply to the patient.
Every day millions of patients rely on medicines supplied by the pharmaceutical industry.