Remote regulatory assessments: Pharma, device groups want more details on FDA guidance

“Trade groups representing the pharmaceutical and medical device industries, while largely supporting the use of remote regulatory assessments (RRAs) as outlined in the US Food and Drug Administration’s (FDA)’s recent draft guidance, questioned how these assessments would work in practice, including how they would be coordinated with onsite inspections, whether they can be leveraged by foreign regulators and how FDA plans to ensure the privacy of companies and personnel that are subject to live-streaming. While FDA has been conducting remote assessments since the start of the pandemic, its guidance, once finalized, would formalize its plan to use these assessments to supplement onsite inspections as it eases out of the pandemic response mode.”

READ MORE!

FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types

"The EU’s eagerly anticipated revision of its good manufacturing practice (GMP) Annex 1 for sterile drug products was released on Thursday after 14 years of development. The revised requirements, which are set to take effect 25 August 2023, govern the manufacturing of sterile drugs made in the EU, as well as imported products. The revised Annex comes after hints earlier this year that it be out in mid-2022. The existing Annex I has been in effect since 2008 and has undergone several proposed revisions since then. The latest proposed revision of the Annex was released for consultation in early 2020 and generated over 2,000 comments. The Annex has been revised to “reflect changes in regulatory and manufacturing environments."

READ MORE!

FDA Lists Mechanisms to Comply With CGMP Requirements for Combination Products

“The EU’s eagerly anticipated revision of its good manufacturing practice (GMP) Annex 1 for sterile drug products was released on Thursday after 14 years of development. The revised requirements, which are set to take effect 25 August 2023, govern the manufacturing of sterile drugs made in the EU, as well as imported products. The revised Annex comes after hints earlier this year that it be out in mid-2022. The existing Annex I has been in effect since 2008 and has undergone several proposed revisions since then. The latest proposed revision of the Annex was released for consultation in early 2020 and generated over 2,000 comments. The Annex has been revised to “reflect changes in regulatory and manufacturing environments.”

READ MORE!

Convergence: Experts see hope for meeting EU MDR deadlines

"With the European Union’s Medical Device Regulation (MDR) grace period ending in 2024, many medical device companies and consultants are nervous about what that means for their products, especially with limited notified body capacity. While some have fretted about getting new certificates of conformity under MDR in time for the 2024 deadline, experts on a panel on the topic at RAPS Convergence 2022 said there is light at the end of the tunnel. During 12 September session on MDR implementation, Gert Bos, CEO of Qserve and President of RAPS’ Board of Directors; Sabina Hoekstra-van den Bosch, regulatory strategy principal at TUV SUD and a RAPS board member; and Kevin Butcher, principal regulatory consultant at NAMSA; offered hope that sponsors will be able to meet their obligations in time."

READ MORE!