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Regulatory Updates
04 September 2020
PHSS Sept 2020 Regulatory Update: New ref stnds/replace batches; Nitrosamines risk assessment »
PHSS Regulatory Update September 2020   available for download for members! Login to view During the last 4 week...
04 August 2020   (0 Comments - view/add)
PHSS August 2020 Regulatory Update: Action Plan on ATMPs; EMA final opinion nitrosamines; FDA new RA »
PHSS Regulatory Update  August  2020 available for download for members! Login to view During the la...
01 July 2020
PHSS Regulatory Update July 2020: EMA and FDA agree new priorities; Multivariate Statistical Process »
PHSS Regulatory Update  July 2020   available for download for members! Login to view During the last...
10 June 2020
PHSS June 2020 Regulatory Update:EU COVID-19: What's new; MHRA GDP process changes »
PHSS Regulatory Update June 2020  available for download for members! Login to view During the last 4 we...
05 May 2020
PHSS May 2020 Reg Update: COVID-19: What's new; Approval of GxP documents WFH; Temporary Policy PPE »
PHSS Regulatory Update  May 2020  available for download for members! Login to view During the...
06 April 2020
PHSS Regulatory Update April 2020: COVID-19; EMA to issue electronic certificates; Q3D(R1) »
PHSS Regulatory Update April 2020  available for download for members! Login to view During the last 4...
06 March 2020   (0 Comments - view/add)
PHSS March 2020 Regulatory Update: Rev 12 of Annex 1; COVID-19; eCTD Specifications »
PHSS Regulatory Update  March 2020   available for download for members! Login to view During the...
07 February 2020   (0 Comments - view/add)
PHSS Feb 2020 Regulatory Update: Avoid shortages of medicines due to Brexit; CMC info for human »
PHSS Regulatory Update  February 2020  available for download for members! Login to view During t...
14 January 2020
PHSS Dec Regulatory Update: EMA Management Board update; Availability / shortages of meds; URPTG »
PHSS Regulatory Update January 2020 available for download for members! Login to view During the l...
13 December 2019
PHSS Dec 2019 Regulatory Update: IVMPs new approach; Pharmeuropa 31.4 released; • Review of coumarin »
PHSS Regulatory Update December 2019     available for download for members! Login to view   Durin...
06 November 2019   (0 Comments - view/add)
PHSS November 2019 Regulatory Update: EMA type I variations; Tissues and cells for human application »
PHSS Regulatory Update November 2019     available for download for members! Login to view   Durin...
07 October 2019   (0 Comments - view/add)
PHSS Oct 2019 Regulatory Update: Ranitidine containing medicinal products; Name change of liposomal »
PHSS Regulatory Update October 2019     available for download for members! Login to view   During...
03 September 2019
PHSS Sept 2019 Regulatory Update: Q&A Imported ATMPs; Sartan Medicines; HHS Announcement »
PHSS Regulatory Update September 2019    available for download for members! Login to view   During...
06 August 2019   (0 Comments - view/add)
PHSS August 2019 Regulatory Update: EU / US MRA fully operational; Medicine shortages; CDER Ann Rep »
PHSS Regulatory Update August 2019     available for download for members! Login to view   During t...
05 July 2019
PHSS July 2019 Regulatory Update: EMA activities; EU-US mutual recognition; Formal Dispute Resoln »
PHSS Regulatory Update July 2019    available for download for members! Login to view   During the l...
03 June 2019   (0 Comments - view/add)
PHSS June 2019 Regulatory Update:EP 10th Edition 10.0-10.2; EDQM inspections »
PHSS June 2019 Regulatory Update   During the last 4 weeks there have been a number of developments in the reg...
14 May 2019
PHSS May Regulatory Update: Noval Therapies; OBERA; When is a REMS Neccessary »
PHSS Regulatory Update May 2019    available for download for members! Login to view   During the la...
09 April 2019
PHSS April 2019 Regulatory Update: EU /USA MRA Q&A; Avoid shortages of medicines; FDA / losartan »
PHSS Regulatory Update April 2019    available for download for members! Login to view   During the...
13 March 2019   (0 Comments - view/add)
PHSS Mar 2019 Regulatory Update: Update on the EDQM review of CEP; Established Conditions; Brexit Q& »
  PHSS Mar 2019 Regulatory Update  available for download for members! Login to view.   During th...
14 February 2019   (0 Comments - view/add)
PHSS Feb 2019 Reg Update: EMA relocation update; FDA’s ongoing investigation into valsartan and ARB »
PHSS Regulatory Update Feb 201 9  available for download for members! Login to view.   During the last 4...
15 January 2019   (1 Comment - view/add)
PHSS Jan 2019 Reg Update: Regulatory Science to 2025; Emerging health threats (EU); Data (GCMP) »
PHSS Regulatory Update Jan 201 9  available for download for members! Login to view.   Here are the ...
03 December 2018
PHSS Dec Reg Update: Industry Stakeholder meeting on Brexit report; Dose Escalation; USA / EU MRA u »
PHSS Regulatory Update Dec 2018   During the last 4 weeks there have been several developments in the regulati...
14 November 2018   (0 Comments - view/add)
PHSS Nov 2018 Reg Update: Safety Features for medicinal prods for human use; FDA on angiotensin »
  PHSS Regulatory Update November 2018   During the last 4 weeks there have been a number of developm...
16 October 2018
PHSS October 2018 Monthly Regulatory Update; Portugal benefit EU-US mutual recognition; biosimilars »
PHSS Regulatory Update October 2018   During the last 4 weeks there have been a number of developments in the...
07 September 2018
PHSS Sept 2018 Regulatory Update: Brexit preparedness; Responsible Person named; Quality Attribute c »
PHSS Regulatory Update September 2018   During the last 4 weeks there have been a number of developments in th...
22 August 2018   (0 Comments - view/add)
PHSS Aug 2018 Reg Update: EMA identifies gaps in industry prep for Brexit; Field Alert Report »
  PHSS Regulatory Update August 2018   During the last 4 weeks there have been a  number o...
05 June 2018
PHSS Jun 2018 Reg Update: Annex 16 Q&A; Outcome of PIC/S Meetings April 2018 »
PHSS Regulatory Update June 2018   During the last 4 weeks there have been several developments in the regulat...
04 May 2018   (0 Comments - view/add)
PHSS May 2018 Regulatory Update; EU template for GMP non-compliance; MHRA VHP Fragility; Liposome dr »
PHSS Regulatory Update May 2018   During the last 4 weeks there have been a number of developments in the regul...
09 April 2018   (0 Comments - view/add)
PHSS Apr 2018 Regulatory Update: MHRA OOS Guidance; Mutagenic imp in pharma carcinogenic risk »
PHSS Regulatory Update April 2018   During the last 4 weeks there have been a number of developments in the re...
06 March 2018   (0 Comments - view/add)
PHSS March 2018 Regulatory Update; Transposition report on Falsified Medicines; Recall Public Notice »
PHSS Regulatory Update March 2018   During the last 4 weeks there have been a number of developments in the re...
08 February 2018   (0 Comments - view/add)
PHSS Feb 2018 Reg Update: EMA surveys Pharma; Good ANDA Submissions; MHRA exit preparations »
  PHSS Regulatory Update February 2018   During the last 4 weeks there have been a number of developm...
10 January 2018   (0 Comments - view/add)
PHSS Jan 2018 Reg Update: Brexit preparations; Annex 1 consultation; Gluten in drug products »
PHSS Regulatory Update January 201 8   During the last 4 weeks there have been a number of developments in th...
13 December 2017   (0 Comments - view/add)
PHSS Dec 2017 Reg Update: Practical Guidance for Brexit; EMA relocation; ATMP GMP »
PHSS Regulatory Update December 2017   During the last 4 weeks there have been a number of developments in the...
08 November 2017   (0 Comments - view/add)
PHSS Nov 2017 Reg Update: Comm DRR (EU) No 2017/1; China accept trial data to speed up drug approval »
PHSS Regulatory Update November 2017   During the last 4 weeks there have been a number of developments in...
08 November 2017   (0 Comments - view/add)
PHSS Oct 2017 Regulatory Update ; EMA relocation preparedness; Perils of antimicrobial resistance »
PHSS Regulatory Update October 2017   During the last 4 weeks there have been a number of developments in the...

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