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Public Assessment Report of review of Topiramate safety data and expert advice on management of risks.
A research report on attitudes to digital mental health technology.
Public Assessment Report of review of Finasteride safety data and expert advice on management of risks.
Report of Isotretinoin Implementation Advisory Expert Working Group regarding recommendations to strengthen the safe use of isotretinoin, the acne medicine commonly known by brand names Roaccutane and Reticutan.
Public Assessment Report of review of valproate safety data and expert advice on management of risks.
Good clinical practice (GCP) referrals received by the MHRA for 2011 to 2020.
The number of applications pending, refused and granted for the early access to medicines scheme (EAMS).
Metrics from pharmacovigilance inspections carried out annually.
The Medicines and Healthcare products Regulatory Agency (MHRA) has undertaken a further review of the safety of albumins manufactured from UK plasma with respect to vCJD.
Report of the Commission on Human Medicines (CHM) Isotretinoin Expert Working Group and plain-language summary of the recommendations.
MHRA good clinical practice (GCP) metrics reports of compliance issues.
A report covering adverse reactions to approved COVID-19 vaccines
Expected time taken to process and grant a marketing authorisation or a variation to a marketing authorisation.
A policy review of the CTDA process, established in July 2021, which governs the validation of antigen and molecular coronavirus (COVID-19) detection tests.
The Medicines and Healthcare products Regulatory Agency (MHRA) assesses its regulatory impact on businesses.
This PAR covers the assessment of the application to increase the pack size of Neutrogena T/Gel Therapeutic Shampoo to a maximum of 500ml as a GSL medicine.
This Public Assessment Report (PAR) covers the assessment of the proposal to add three new pack sizes (3, 4 & 6 cannisters) to the licence for Nicorette QuickMist 1mg/spray mouthspray and Nicorette QuickMist Smart T…
This PAR covers the assessment of the proposal to make Sudafed Plus Blocked Nose 1mg/50mg/ml nasal spray solution, containing xylometazoline hydrochloride 1mg/ml (0.1% w/v) and dexpanthenol 50mg/ml (…
Public Assessment Report on our review of epidemiological data for cardiovascular safety.
This PAR covers the assessment of the proposal to make Buscopan IBS Relief, Hyoscine Butylbromide 10mg tablets available through general retail outlets.
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