Welcome to the pharmaceutical industry area of the MHRA website. This section, which has been developed following feedback from users, provides targeted links to information throughout the site, as well as content relevant to the industry.
If you have any feedback on this section and how we can improve it please email webupdates@mhra.gsi.gov.uk
There is a link at the top of every page of the MHRA website which links directly to the new section.
News and hot topics
Building on the success of the sell-out 2009 Pharmacovigilance Inspections Symposium, this event, to be held in London on 23 November 2010, is an opportunity for organisations involved in pharmacovigilance activities to hear current updates and insights from MHRA experts.
This annual event, to be held in London on 2 November, provides an insight into current advertising hot topics and an explanation of the regulations and MHRA expectations.
This event, to be held in London on 10 February, will focus on international aspects of the development of appropriate medicines for children in addition to providing regulatory and strategic updates at a European and national level.
The 7th Annual TOPRA Symposium, organised in conjunction with the MHRA, is to be held in London on 4 October 2010. This important annual symposium is now recognised as a key event in the European calendar of all those working in the healthcare regulatory affairs arena.
We have today published a new MHRA strategy for the enforcement of medicines and medical device legislation.
The section has been updated with the latest information and restructured to help different types of users to find what they need more easily.
Go to the news and hot topics page
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Fees
This page includes the fees payable for the regulation of medicines, guidance for periodic fees, and how to make payments to the MHRA.
Go to the fees page
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Clinical trials
This page provides links to information on applying for a clinical trial authorisation (CTA), maintaining a CTA, safety reporting and Good Clinical Practice (GCP).
Go to the clinical trials page
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Manufacturing and wholesaling
This page provides links to information about manufacturer's and wholesale dealer's licences, including the registers of licensed sites and lists of new, terminated and revoked licences, importing and exporting, and the associated legislation and guidance.
Go to the manufacturing and wholesaling page
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Over-the-counter medicines
This page provides links to the latest information about over-the-counter (OTC) medicines including products containing codeine, pseudoephedrine and children's cough and cold medicines and reclassification of medicines, as well as questions and answers on the new OTC Product Licensing Assessment Team (PLAT) 7.
Go to the over-the-counter medicines page
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Legislation, guidance and policy
This page provides links to information on medicines legislation, guidance and policy. It includes an overview of medicines legislation, including preparing a medicinal product for sale in the UK or EU marketplace, how the MHRA develops policy, and current MHRA consultations relevant to industry.
Go to the legislation, guidance and policy page
Inspection
This page provides links to information about the different types of inspection, including the inspection process and risk-based inspections, as well as the associated legislation and guidance.
Go to the inspection page
Safety and pharmacovigilance
This page provides links to information about safety and pharmacovigilance, including adverse drug reaction reporting, periodic safety update reports, 'Drug Safety Update', as well as the associated legislation and guidance.
Go to the safety and pharmacovigilance page
Medicines for children
This page provides links to information about the regulation of medicines for children, including the requirements for submission of paediatric data and the European paediatric work-sharing procedures.
Go to the medicines for children page
