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Regulatory Updates
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...
13 September 2017   (0 Comments - view/add)
PHSS Sept 2017 Regulatory Update : Medicine Inspections EU-US cooperation; Ireland - Safeguarding »
PHSS Regulatory Update September 2017   During the last 4 weeks there have been a number of developments in th...
02 August 2017   (0 Comments - view/add)
PHSS August 2017 Reg Update: Prohibition of supply; Product identifier reqs; Safety feature on pckg »
  PHSS August 2017 Regulatory Update   INTRODUCTION During the last 4 weeks, there hav...
03 July 2017   (0 Comments - view/add)
PHSS July 2017 Reg Update: GMP Short Notice and Unannounced Insp; Responsible Pers: requirements »
PHSS Regulatory Update July 2017   During the last 4 weeks there have been a number of developments in the reg...
05 June 2017   (0 Comments - view/add)
PHSS June 2017 Regulatory Update ;Reporting irregularities; Brexit - Notice to marketing »
PHSS Regulatory Update June 2017   During the last 4 weeks there have been a number of developments in the re...
08 May 2017   (0 Comments - view/add)
PHSS May 2017 Regulatory Update ; Consequences of Brexit; EU ATMP GMP; Water for Pharm Use »
PHSS May Regulatory Update 2017   This month's update includes a number of developments in the regulation of t...
10 April 2017   (0 Comments - view/add)
PHSS Apr 2017 Regulatory Update ; EU and US MRA - regulators agree on mutual recog. of inspections »
PHSS April Regulatory Update 2017   This month's update includes a number of developments in the regulation of...
09 March 2017   (0 Comments - view/add)
PHSS Mar 2017 Regulatory Update : Annex 16 QP cer & batch rel FAQ; FDA Ban on Powder »
PHSS March Regulatory Update 2017   During the last 4 weeks there have been a number of developments in the re...
09 February 2017   (0 Comments - view/add)
PHSS Feb 2017 Regulatory Update: 2016 MHRA GMP symposium; FDA improves foreign inspection program; A »
PHSS February Regulatory Update 2017   During the last 4 weeks there have been a number of developments in the...
26 January 2017   (0 Comments - view/add)
PHSS Jan 2017 Regulatory Update; Guidelines Chemistry of active substances and Elec subm on CE appli »
PHSS January Regulatory Update 2017   Welcome to the 1st regulatory update of 2017. During the last 4 weeks th...
04 January 2017
PHSS Dec 2016 Regulatory Update ; EDQM share info w Japan reg; Safety Testing of drug metabolites »
PHSS December Regulatory Update 2016   During the last 4 weeks there have been a number of developments in...

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