Latest news and insights from ESPL Latest news and insights from ESPL The world of regulatory affairs doesn’t stand still, so it’s important to stay informed. Here you can keep up to date with the latest news and insights. Featured articles Quarter 3 - News Letter 2023 As part of the new contacts and professional growth of ESPL, a regular news letter is made to keep ESPL contacts upto date with European news. Please see below. A link... Read more ESPL and Community Development: Hockey Sponsorship ESPL is an advocate of a healthy work-life balance, and likes to support the activities of our team members. Our website gives a brief introduction to the variety of activities that... Read more All articles Quarter 3 - News Letter 2023 As part of the new contacts and professional growth of ESPL,... ESPL and Community Development: Hockey Sponsorship ESPL is an advocate of a healthy work-life balance, and likes... March News Letter 2023 As part of the new contacts and professional growth of ESPL,... Sponsor of the Shetland Folk Festival 2023 We all know that activities and events outside of work are... March News Letter 2022 As part of the new contacts and professional growth of ESPL,... Reflection on 2021 With the end of 2021 fast approaching, it is worth reflecting... October News Letter 2021 As part of the new links and growth of ESPL, a... We’re Celebrating ESPL as a company was established on 16 July 1996. Today... Welcome to the launch of ESPL’s new website ESPL is excited to announce the launch of its new website.... Medicines: marketing authorisation holders submission of Nitrosamine risk evaluation MAHs should review their manufacturing processes to identify and,... Medical devices clinical investigations during the coronavirus (COVID-19) outbreak Advice for investigators and sponsors of ongoing clinical investigations... MHRA guidance on coronavirus (COVID-19) We are producing guidance and information for industry, healthcare professionals and... EMA - COVID-19: how EMA fast-tracks development support and approval of medicines and vaccines As researchers race to develop vaccines and therapeutics against COVID-19, EMA... EMA - Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 In a high-level meeting on COVID-19 policies, organised by... MEDSCAPE: Treatment of Coronavirus Disease 2019 (COVID-19): Investigational Drugs and Other Therapies OverviewCoronavirus disease 2019 (COVID-19) is defined as illness caused by... HPRA - MDCG Endorsed Guidance on MDR Clinical Investigations and Evaluations The Medical Device Coordination Working Group (MDCG) on Clinical Investigation... FDA publishes MAPP, Collaborative Identification, Evaluation, and Resolution of a NISS. (4121.3) Today, the Center for Drug Evaluation and Research (CDER)... HPRA - Guide to New applications and variations to Manufacturer’s Authorisations This document provides guidance on applying to the HPRA for a... Information from the: EMA. ECA and EDQM EMA ICH M9 on biopharmaceutics classification system based biowaivershttps://www.ema.europa.eu/en/ich-m9-biopharmaceutics-classification-system-based-biowaivers Regulatory and... FDA: Guidance Agenda: Guidance Documents CBER is Planning to Publish During 2020 This is the list of guidance topics CBER is considering for... Second corrigenda to the MDR and IVDR published The EU Commission has now published the second corrigendum... BREXIT-UK and Ireland-Guidance in case of a no-deal Brexit Due to the possibility of a no-deal brexit, the UK MHRA... US FDA announces availability of ICH draft guidance on Clinical Studies E8(R1) The U.S. FDA has announced the availability of a draft guidance... BP and USP formalises partnership The British Pharmacopoeia (BP) and United States Pharmacopeia (USP) signed a... EMA/FDA analysis shows high degree of alignment in MA/NDA decisions between EU and US EMA and the US Food and Drug Administration (FDA) are aligned... EMA/FDA: Supporting medicine developers in generating quality data packages in early access approaches: workshop report published EMA and the US Food and Drug Administration (FDA) have published... BREXIT: Contingency legislation covering regulation of medicines and medical devices in a no deal scenario Leaving the EU with a deal remains the Government’s top priority.... UK consults on 'no deal' Brexit SPC waiver law Generic and biosimilar medicines manufacturers will continue to benefit from... FDA - Pre-Assigned NDA, IND, BLA and DMF number requests through the CDER NextGen Portal from the 19th of August Starting August 19, 2019, pre-assigned NDA, IND, BLA and DMF number... FDA issues a revised Draft Guidance - Rare Pediatric Disease Priority The U.S. Food and Drug Administration issued a revised draft guidance, Rare... Recently Posted Guidance Documents from the FDA & CDRH New Update Guidance Documents7/26/2019 - Delayed Graft Function in Kidney Transplantation: Developing Drugs... MHRA launches consultation on how to best engage patients and the public The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched... As of 1 January 2020 the eCTD is mandatory for ALL CEP applications including notifications, revision, renewal and new applications ccording to the EDQM roadmap for electronic submissions for CEP applications,... Exporting active substance manufactured in the UK in a no deal Brexit Information on the ‘Written Confirmation’ process, for active substances manufactured in... Early access to medicines scheme applications: pending, refused, granted The number of applications pending, refused and granted for the early... EMA - Bacterial lysate medicines for respiratory conditions to be used only for prevention of recurrent infections EMA is recommending that bacterial lysate medicines authorised for respiratory conditions... Certification procedure: revised documents July 2019 The EDQM has revised the following documents to reflect current practice and... Additional country to benefit from EU-US mutual recognition agreement for inspections On 26 June 2019, Germany was included into the mutual recognition... Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate Term and preterm neonates represent the most vulnerable subgroup of... MHRA Falsified medicines 5 months in A new post, “How the implementation of Safety Features progresses 5... FDA - Recently Posted Guidance Documents · 7/1/2019 - Drug Abuse and Dependence Section of Labeling for... European Task Force which address problems with medicines supply has published two documents The European Union task force set up to address problems with... EU Publishes MDR fact Sheet for Health Care professionals and institutions Center for Food Safety and Applied Nutrition Constituent Update - FDA Announces New Qualified Health Claims FDA Announces New Qualified Health Claims for EPA and DHA Omega-3... Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs The FDA has published the guidance for industry entitled, “Providing Regulatory Submissions... MHRA plans to apply AQbD principle The MHRA opened a three-month public consultation (until August 31, 2019) on... Another Notified Body Bows Out Ahead of EU MDR: 'Investment Too High’ Swiss notified body (NB) QS Zürich AG has decided that it... ISO 20916:2019 In vitro diagnostic medical devices -- Clinical performance studies using specimens from human subjects This document defines good study practice for the planning, design, conduct,... Posted Guidance Documents by the FDA 6/13/2019 Testing for Biotin Interference in In Vitro Diagnostic Devices: Draft... Guidance for pharmaceutical companies on how to prepare and review summaries of product characteristics (SmPCs) for human medicines. Published EMA Slideshow presentation containing 28 slides about general principals, advice... EU-FDA Mutal Recognition Agreement - LU + NL Added Two additional countries to benefit from EU-US mutual recognition agreement for... EMA Issues New Draft Guideline for Drug-Device Combinations (DDCs) Quality Requirements for Drug-Device Combinations EMA/CHMP/QWP/BWP/259165/2019 dated 29th May 2019:... Call for data on ingredients used in cosmetic products This is a call for data on the ingredients: Gold (nano),... UK MHRA Posts Consultation on QbD for Analytical Quality by Design Consultation on the application of Analytical Quality by Design (AQbD) principles... MHRA Inspectorate Issues Blog on GMP Symposium MHRA GMP symposium 2019https://mhrainspectorate.blog.gov.uk/2019/06/04/the-2018-gmp-symposium/ FDA CDRH posted new items Webcast Links posted for June 19-20, 2019 Circulatory System Devices PanelThe... FDA Draft Guidance on Development of Therapeutic Protein Biosimilars FDA issues Draft Guidance for Industry on Development of Therapeutic Protein... FDA Statement on Opioid Pain Medicines fixed quantity packaging Statement on FDA’s request for information on requiring fixed-quantity blister packaging... EU HMA Issues Guidence on Publishing ASMFs for eCTD Issued April (but of interest to publishing teams)Q&A Publishing ASMFs for... April/May Latest Headlines GMP - MUTUAL RECOGNITION AGREEMENT WITH THE USAEU Mutual Recognition agreements... 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Quarter 3 - News Letter 2023 As part of the new contacts and professional growth of ESPL, a regular news letter is made to keep ESPL contacts upto date with European news. Please see below. A link... Read more ESPL and Community Development: Hockey Sponsorship ESPL is an advocate of a healthy work-life balance, and likes to support the activities of our team members. Our website gives a brief introduction to the variety of activities that... Read more
Quarter 3 - News Letter 2023 As part of the new contacts and professional growth of ESPL,... ESPL and Community Development: Hockey Sponsorship ESPL is an advocate of a healthy work-life balance, and likes... March News Letter 2023 As part of the new contacts and professional growth of ESPL,... Sponsor of the Shetland Folk Festival 2023 We all know that activities and events outside of work are... March News Letter 2022 As part of the new contacts and professional growth of ESPL,... Reflection on 2021 With the end of 2021 fast approaching, it is worth reflecting... October News Letter 2021 As part of the new links and growth of ESPL, a... We’re Celebrating ESPL as a company was established on 16 July 1996. Today... Welcome to the launch of ESPL’s new website ESPL is excited to announce the launch of its new website.... Medicines: marketing authorisation holders submission of Nitrosamine risk evaluation MAHs should review their manufacturing processes to identify and,... Medical devices clinical investigations during the coronavirus (COVID-19) outbreak Advice for investigators and sponsors of ongoing clinical investigations... MHRA guidance on coronavirus (COVID-19) We are producing guidance and information for industry, healthcare professionals and... EMA - COVID-19: how EMA fast-tracks development support and approval of medicines and vaccines As researchers race to develop vaccines and therapeutics against COVID-19, EMA... EMA - Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 In a high-level meeting on COVID-19 policies, organised by... MEDSCAPE: Treatment of Coronavirus Disease 2019 (COVID-19): Investigational Drugs and Other Therapies OverviewCoronavirus disease 2019 (COVID-19) is defined as illness caused by... HPRA - MDCG Endorsed Guidance on MDR Clinical Investigations and Evaluations The Medical Device Coordination Working Group (MDCG) on Clinical Investigation... FDA publishes MAPP, Collaborative Identification, Evaluation, and Resolution of a NISS. (4121.3) Today, the Center for Drug Evaluation and Research (CDER)... HPRA - Guide to New applications and variations to Manufacturer’s Authorisations This document provides guidance on applying to the HPRA for a... Information from the: EMA. ECA and EDQM EMA ICH M9 on biopharmaceutics classification system based biowaivershttps://www.ema.europa.eu/en/ich-m9-biopharmaceutics-classification-system-based-biowaivers Regulatory and... FDA: Guidance Agenda: Guidance Documents CBER is Planning to Publish During 2020 This is the list of guidance topics CBER is considering for... Second corrigenda to the MDR and IVDR published The EU Commission has now published the second corrigendum... BREXIT-UK and Ireland-Guidance in case of a no-deal Brexit Due to the possibility of a no-deal brexit, the UK MHRA... US FDA announces availability of ICH draft guidance on Clinical Studies E8(R1) The U.S. FDA has announced the availability of a draft guidance... BP and USP formalises partnership The British Pharmacopoeia (BP) and United States Pharmacopeia (USP) signed a... EMA/FDA analysis shows high degree of alignment in MA/NDA decisions between EU and US EMA and the US Food and Drug Administration (FDA) are aligned... EMA/FDA: Supporting medicine developers in generating quality data packages in early access approaches: workshop report published EMA and the US Food and Drug Administration (FDA) have published... BREXIT: Contingency legislation covering regulation of medicines and medical devices in a no deal scenario Leaving the EU with a deal remains the Government’s top priority.... UK consults on 'no deal' Brexit SPC waiver law Generic and biosimilar medicines manufacturers will continue to benefit from... FDA - Pre-Assigned NDA, IND, BLA and DMF number requests through the CDER NextGen Portal from the 19th of August Starting August 19, 2019, pre-assigned NDA, IND, BLA and DMF number... FDA issues a revised Draft Guidance - Rare Pediatric Disease Priority The U.S. Food and Drug Administration issued a revised draft guidance, Rare... Recently Posted Guidance Documents from the FDA & CDRH New Update Guidance Documents7/26/2019 - Delayed Graft Function in Kidney Transplantation: Developing Drugs... MHRA launches consultation on how to best engage patients and the public The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched... As of 1 January 2020 the eCTD is mandatory for ALL CEP applications including notifications, revision, renewal and new applications ccording to the EDQM roadmap for electronic submissions for CEP applications,... Exporting active substance manufactured in the UK in a no deal Brexit Information on the ‘Written Confirmation’ process, for active substances manufactured in... Early access to medicines scheme applications: pending, refused, granted The number of applications pending, refused and granted for the early... EMA - Bacterial lysate medicines for respiratory conditions to be used only for prevention of recurrent infections EMA is recommending that bacterial lysate medicines authorised for respiratory conditions... Certification procedure: revised documents July 2019 The EDQM has revised the following documents to reflect current practice and... Additional country to benefit from EU-US mutual recognition agreement for inspections On 26 June 2019, Germany was included into the mutual recognition... Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate Term and preterm neonates represent the most vulnerable subgroup of... MHRA Falsified medicines 5 months in A new post, “How the implementation of Safety Features progresses 5... FDA - Recently Posted Guidance Documents · 7/1/2019 - Drug Abuse and Dependence Section of Labeling for... European Task Force which address problems with medicines supply has published two documents The European Union task force set up to address problems with... EU Publishes MDR fact Sheet for Health Care professionals and institutions Center for Food Safety and Applied Nutrition Constituent Update - FDA Announces New Qualified Health Claims FDA Announces New Qualified Health Claims for EPA and DHA Omega-3... Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs The FDA has published the guidance for industry entitled, “Providing Regulatory Submissions... MHRA plans to apply AQbD principle The MHRA opened a three-month public consultation (until August 31, 2019) on... Another Notified Body Bows Out Ahead of EU MDR: 'Investment Too High’ Swiss notified body (NB) QS Zürich AG has decided that it... ISO 20916:2019 In vitro diagnostic medical devices -- Clinical performance studies using specimens from human subjects This document defines good study practice for the planning, design, conduct,... Posted Guidance Documents by the FDA 6/13/2019 Testing for Biotin Interference in In Vitro Diagnostic Devices: Draft... Guidance for pharmaceutical companies on how to prepare and review summaries of product characteristics (SmPCs) for human medicines. Published EMA Slideshow presentation containing 28 slides about general principals, advice... EU-FDA Mutal Recognition Agreement - LU + NL Added Two additional countries to benefit from EU-US mutual recognition agreement for... EMA Issues New Draft Guideline for Drug-Device Combinations (DDCs) Quality Requirements for Drug-Device Combinations EMA/CHMP/QWP/BWP/259165/2019 dated 29th May 2019:... Call for data on ingredients used in cosmetic products This is a call for data on the ingredients: Gold (nano),... UK MHRA Posts Consultation on QbD for Analytical Quality by Design Consultation on the application of Analytical Quality by Design (AQbD) principles... MHRA Inspectorate Issues Blog on GMP Symposium MHRA GMP symposium 2019https://mhrainspectorate.blog.gov.uk/2019/06/04/the-2018-gmp-symposium/ FDA CDRH posted new items Webcast Links posted for June 19-20, 2019 Circulatory System Devices PanelThe... FDA Draft Guidance on Development of Therapeutic Protein Biosimilars FDA issues Draft Guidance for Industry on Development of Therapeutic Protein... FDA Statement on Opioid Pain Medicines fixed quantity packaging Statement on FDA’s request for information on requiring fixed-quantity blister packaging... EU HMA Issues Guidence on Publishing ASMFs for eCTD Issued April (but of interest to publishing teams)Q&A Publishing ASMFs for... April/May Latest Headlines GMP - MUTUAL RECOGNITION AGREEMENT WITH THE USAEU Mutual Recognition agreements...
