PIC/S raises concerns about EC plan for advanced therapy GMP


PIC/S raises concerns about EC plan for advanced therapy GMP
  1. PIC/S raises concerns about EC plan for advanced therapy GMP
    Separate GMP rules for advanced therapies would put patients at risk according to the PIC/S, which has called on the European Commission (EC) to rethink the…
    Health

The EC mooted separate manufacturing guidelines for advanced therapy medicinal products (ATMP) in 2015 when it suggested the variability of gene therapy, cell therapy or engineered tissues relative to small molecule drugs may require specific rules.

In September the EC published draft guidelines for consultation.  

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) provided its feedback in a letter published last week ., raising concerns the plan will put patients at risk and damage international harmonization efforts.

By lowering the GMP requirements for ATMPs, the European Commission is not only exposing patients to an increased risk to their health; it is also engaging its individual and collective responsibility for any health incident (and related court action) that lower ATMP standards may occasion. We would like you to duly ponder this aspect.”

Manufacturing disharmony

The PIC/S – which represents regulators which oversee the safety of drugs in multiple markets worldwide – also suggested separate ATMP GMP guidelines will undermine long-term efforts to align GMP guidelines.

Since 1989, both [PIC/S GMP and EU GMP] Guides have been developed in parallel and systematically kept aligned on the basis of a harmonised consultation procedure, which PIC/S and the EMA have duly and respectfully implemented.

Your decision to amend Annex 2 and repeal Annex 13 of the EU GMP Guide is a serious setback in terms of co-operation between the EU and PIC/S. It is very unfortu…

  1. Half of CMOs unprepared for serialisation requirements, says Tracelink

    In-pharmatechnologist.com - Health
    As many as 400 contract manufacturing organisations (CMOs) will not be ready for upcoming US and EU track-and-trace regulations, says supply chain services firm…
  2. Mylan confirms plan to close Meda Soma plant in Illinois

    In-pharmatechnologist.com - Health
    Mylan will close a manufacturing site in Decatur, Illinois that it gained when it bought Swedish drug maker Meda last…
  3. Lionel Messi banned for four international matches for swearing at match official

    Theage.com.au - Health
    03.28 / 16:46 www.theage.com.au
    Argentina forward Lionel Messi has been banned from their next four competitive internationals, starting with Tuesday's World Cup qualifier in Bolivia, for swearing at a match official, FIFA said on…
  4. Permira to buy Lyophilization Services of New England

    In-pharmatechnologist.com - Health
    Private equity fund Permira has announced its intention to buy freeze drying firm Lyophilization Services of New England Inc…
  5. I gave up TV for a year. This is what I got done instead

    Theage.com.au - Health
    03.28 / 15:06 www.theage.com.au
    For all the time we spend with it, TV doesn't repay us very nicely. People who watch more television are generally unhappier, heavier and worse sleepers, and have a higher risk of death over a defined length of…
  6. Dutch health council says human embryos can be created for research

    Dutchnews.nl - Health
    03.28 / 14:00 dutchnews.nl
    The Dutch health council is recommending that the law covering human embryos be changed to allow the creation of…
  7. Newsreader Talitha Cummins sues Channel Seven over alleged maternity leave sacking

    Theage.com.au - Health
    03.28 / 13:29 www.theage.com.au
    Last year, when Talitha Cummins took leave from Weekend Sunrise to give birth, her colleagues urged a speedy return. This exchange could prove crucial in a looming court stoush between Seven West Media and Cummins, who claims she was unfairly dismissed nine weeks into her maternity…
  8. Drug overdose deaths rise in Victoria

    Theage.com.au - Health
    03.28 / 13:01 www.theage.com.au
    More than 470 Victorians died of a drug overdose in 2016, figures released by the Coroner's Court on Wednesday…
  9. Step forward in fight to rid Victorian hospitals of deadly superbugs

    Theage.com.au - Health
    03.28 / 13:01 www.theage.com.au
    Not only did Mark Hanson become a paraplegic at age 22, the nightmare continued when he caught a superbug in hospital…
  10. 'I totally condemn his actions' London attacker Khalid Masood's wife speaks out

    Theage.com.au - Health
    03.28 / 13:01 www.theage.com.au
    London: The wife of Khalid Masood says she is "saddened and shocked" by his attack on Westminster and "totally" condemns his …
  11. Eurofins pumping $5m into a UK biopharmaceutical testing site

    In-pharmatechnologist.com - Health
    Eurofins will expand its UK biopharmaceutical testing offering through a £4m ($5m) facility in Livingston, …
  12. Lilly: Tax reforms would release $150m to further support US manufacturing

    In-pharmatechnologist.com - Health
    Eli Lilly will invest $850m in its US operations this year but warns the country’s antiquated tax system leaves the firm at a competitive d…
  13. EMA looks to suspend 331 drugs due to ‘misrepresentation of study data’ at Indian CRO

    In-pharmatechnologist.com - Health
    Sandoz and Aurobindo are among drugmakers which will need to provide alternative bioequivalence data after the EMA recommended suspension of medicines tested by Micro Therapeutic Research …
  14. Alexion licenses mRNA delivery tech from Arbutus in potential $82.5m deal

    In-pharmatechnologist.com - Health
    Alexion Pharmaceuticals will use the LNP delivery licensed from Arbutus Biopharma as part of its messenger RNA therapeutics development partnership with Moderna…
  15. 'King George Square - the ashtray of the CBD': Petitioners want smoking ban

    Theage.com.au - Health
    03.28 / 12:14 www.theage.com.au
    King George Square is one of the few places left in the CBD where you can legally smoke. Petitioners want a ban…
  16. AFLW: Erin Phillips wins competition's inaugural best and fairest award

    Theage.com.au - Health
    03.28 / 12:14 www.theage.com.au
    Adelaide premiership co-captain Erin Phillips has capped her outstanding AFLW season by winning the best and fairest…
  17. Australia v UAE 2017: Socceroos fail to silence critics

    Theage.com.au - Health
    03.28 / 12:14 www.theage.com.au
    Australia's hopes of reaching a fourth consecutive World Cup are back on track after snapping their four-game winless streak but a disjointed victory over UAE did little to silence critics of their recent…
  18. Australia v UAE 2017: Coach Mahdi Ali steps down after loss to Socceroos

    Theage.com.au - Health
    03.28 / 12:14 www.theage.com.au
    United Arab Emirates coach Mahdi Ali announced his resignation immediately after losing to the Socceroos in…
  19. Dutch scientists discover key to ‘reverse ageing’

    Dutchnews.nl - Health
    03.28 / 12:10 dutchnews.nl
    Studies carried out by Dutch scientists have resulted in a major breakthrough in the anti-ageing process which could ultimately…
  20. A light breakfast can cut some cancer drug doses, Dutch researchers say

    Dutchnews.nl - Health
    03.28 / 12:10 dutchnews.nl
    Although pharmaceutical firms recommend that many anti-cancer drugs should be taken on an empty stomach, researchers at Radboud teaching…