GMP News - Regulatory Affairs

04.05.22

EMA´s Cannabis Glossary

The glossary summarizes existing scientific and legislative terminology relevant for medicinal products containing Cannabis-derived active substances. What is CBD oil and what is Cannabis oil?

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27.04.22

Requirements for Styrene Block Copolymers

Following the previously published Ph. Eur drafts for COC / COP, a new Ph. Eur. chapter 3.1.18. Styrene block copolymers for containers and closures for parenteral preparations and ophthalmic preparations has been proposed in Pharmeuropa.

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26.04.22

EDQM Survey: TOC to replace Test for oxidisable Substances in Sterile WFI

The EDQM has launched a survey on whether the test for oxidisable substances for sterilised water for injection (Sterile WFI) in the European Pharmacopoeia should be changed to a test for total organic carbon (TOC). Read more.

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26.04.22

Product Transfer: Is a Transfer Plan a required GMP Document?

A frequently asked question in courses on product / technology transfer is: Is a transfer plan a required GMP document?

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13.04.22

Still Issues with CBD Products

The FDA issued again Warning Letters to several companies for selling Cannabidiol (CBD) products with misleading product claims.

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05.04.22

EDQM: Availability of Reference Standards

The EDQM (European Directorate for the Quality of Medicines & HealthCare) regularly updates the list of available reference standards on its website.

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05.04.22

EDQM implements "Real-Time Remote Inspections"

Due to the Corona pandemic and the resulting changes in working conditions, a new type of inspection was needed in addition to classical on site inspections of API manufacturing facilities and paper-based GMP assessments. For this purpose, the pilot project for so-called "Real-Time Remote Inspections (RTEMIS)" was created.

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05.04.22

MHRA GCP Inspector´s Experience during the COVID-19 Pandemic

The MHRA GCP Inspectors provided insight in their experience during the COVID-19 Pandemic. Although they have their limitations, remote GCP inspections have proven to be very effective and critical findings have been identified.

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05.04.22

Recent Findings in GCP Inspections

The EMA published the Annual report of the Good Clinical Practice Inspectors’ Working Group (GCP IWG) containing examples of findings observed during recent GCP inspections. In addition, the 3-year work plan for the GCP IWG has been released.

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05.04.22

Version 5 of the Q&As regarding the Clinical Trials Regulation

What is the final deadline for submission of a clinical trial according to the former CTD rules? The European Commission published an updated Version 5 of the Questions & Answers relating to the CTR which came into application on 31 January 2022. The revision includes new Q&As regarding arrangements for the transitional period.

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05.04.22

EMA: Update of the "IRIS Guidance Documents"

Both the "IRIS guide to registration and RPIs" and the "IRIS guide for applicants" were updated in February and published on the EMA website.

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05.04.22

Centralised Procedures: Update of the Q&A Document

In March 2022, the European Medicines Agency (EMA) published on its website the updated and revised version of the "Questions & Answers (Q&A)" document "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure" regarding centralised procedures.

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23.03.22

EDQM: CEP Application Templates redesigned

Due to the introduction of new IT systems, the EDQM has now also adapted the forms for applying for new CEPs, changes to CEPs and so-called "sister files" and plans to implement them on 01 April 2022.

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16.03.22

UK: Public Consultation on new Clinical Trials Legislation and Impact on IMPs

Following the start of the application of the EU CTR on 31 January 2022, the MHRA has launched an 8-week public consultation on proposals for legislative changes for clinical trials. Will the UK align with the EU CTR requirements, e.g. regarding labelling of IMPs?

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16.03.22

Will there be an EU Herbal Monograph for Cannabis?

EMA´s HMPC announced the start of several activities relating to regulatory requirements and standards for medical cannabis. Amongst others, the HMPC will establish some basic information regarding existing standard requirements for herbal medicinal products (HMPs).

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