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FDA Update
Guidance for Industry ANDA Submissions-Prior Approval Supplements Under GDUFA DRAFT GUIDANCE.
16th July 2014
For more information or an estimate, contact us »
Written Confirmations for export of Active Substances manufactured in the UK Post Brexit
18th June 2019
MHRA GDP Pilot Scheme - OBERA: Office Based Evaluation and Risk Assessment programme
26th April 2019
Use eCTD for all regulatory activities in National Procedures (NP) by 1 January 2019
18th January 2019
Revised guideline to assess risk of human medicines for the environment
4th December 2018
Submitting regulatory information on medical products if there’s no Brexit deal
25th September 2018
Report from EMA - Industry survey on Brexit preparedness
13th July 2018
Variations Required: Concomitant use of benzodiazepines / benzodiazepine like products and opioids
3rd May 2018
MHRA's Guidance on GxP data integrity
28th March 2018
Brexit Update: Ireland and Denmark to drop fees for RMS transfer post-brexit
13th February 2018
An overview of the EU’s orphan designation programme - EMA Factsheet
2nd January 2018
EMA to relocate to Amsterdam, the Netherlands
20th November 2017
EU-US mutual recognition of inspections of medicines manufacturers enters operational phase
1st November 2017
Better labelling of excipients for safe use of medicines
16th October 2017
MHRA's recently published guidance on human factors
19th September 2017
EMA's Revised guideline on first-in-human clinical trials
9th August 2017
EMA's Pre-submission checklist for type II variation applications
11th July 2017
EMA Regulatory Guidance for industry to prepare for the UK’s withdrawal from the EU
1st June 2017
EMA Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use
3rd May 2017
Changes to MHRA payment of fees
31st March 2017
New MedRegs blog
9th February 2017
Standards for biological medicines - understanding them and how they make a difference
13th January 2017
Notification of intent to import an unlicensed medicinal product
7th December 2016
Export medical devices: special rules
8th November 2016
EU-US collaboration to boost medicine development for rare diseases
28th September 2016
Pharmacovigilance Inspection Metrics Report April 2015 - March 2016
6th September 2016
MHRA - Updated Statement On The Outcome of The Brexit Referendum
21st July 2016
Introduction of a 'regulatory contact point' for marketing authorisation holders
17th June 2016
Single, central platform now mandatory for all PSURs
10th June 2016
CMDh Update For New Applications
15th April 2016
EMA update
19th January 2016
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