Regulis are pleased to announce the award of another multicentre global clinical trial project. Read more “Clinical Trial Project Award”
Year: 2014
A Quality Success
‘International Health Partners (IHP) is a charity dedicated to improving access to health care and medicines in the developing world. Read more “A Quality Success”
Do you sell, supply or procure medicines?
Any company or individual who wishes to sell, supply or procure medicinal products within the EU to anyone other than the end-user, must hold a Wholesale Distribution Authorisation or WDA(H). Read more “Do you sell, supply or procure medicines?”
EMA starts review of ibuprofen medicines
The EMA has announced that the Pharmacovigilance and Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen (i.e., from oral forms). Read more “EMA starts review of ibuprofen medicines”
New EU Clinical Trials Regulation published
On 27 May 2014, the Clinical Trials Regulation was published in the Official Journal of the EU. The regulation, which will replace the existing EU Clinical Trials Directive, will streamline the authorisation process and harmonise requirements for clinical trials in Europe. Read more “New EU Clinical Trials Regulation published”
MHRA guidance note 14 on the supply of unlicensed medicinal products (‘specials’) updated
The MHRA guidance on the supply of unlicensed medicinal products (‘specials’) has been updated. This guidance has been updated following the consolidation of medicines legislation into the Human Medicines Regulations 2012 and takes into account the outcomes of relevant European court cases. Read more “MHRA guidance note 14 on the supply of unlicensed medicinal products (‘specials’) updated”
Launch of the new MHRA Process Licensing Portal
The MHRA will shortly be rolling out a new web application for the submission of Wholesale Distribution Authorisations WDA(H) applications and new registrations for Active Substance manufacture, importation or distribution (API). Read more “Launch of the new MHRA Process Licensing Portal”
Voluntary parallel scientific advice with NICE and the MHRA
On 28th January 2014, the MHRA reminded companies that it welcomes requests from licence applicants for a joint scientific advice meeting with NICE to discuss their development plans for medicinal products. Read more “Voluntary parallel scientific advice with NICE and the MHRA”
SCOPE project to improve EU pharmacovigilance capabilities
A three year EU-wide pharmacovigilance project is being coordinated by the MHRA to help member states meet the requirements of the new pharmacovigilance legislation. This ‘Joint Action’ is called Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE). Read more “SCOPE project to improve EU pharmacovigilance capabilities”