k.janecek2023-03-29T15:53:12+00:00September 16th, 2021|Categories: Clinical Trial, Compliance, Europe, FDA, Innovation, Regulatory|Tags: Clinical Trial, Complex Generic Drugs, DRUGS, EMA, Europe, European Union, FDA, Generic Drug, Hybrid Medicines, Innovation, medicines, PSA, Regulatory, USA|
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched a new pilot program to provide parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines, as they are called in the [...]
k.janecek2023-03-29T15:54:00+00:00July 21st, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: European Union, France, IVDR, MDR, notifiedbody, Western Europe|
The French National Agency for Medicines and Health Products Safety has updated its Guidance and templates for consultation for medical devices with ancillary medicinal substances. Scientific opinion must be requested for any new medical device or device-drug combination product, [...]
k.janecek2023-03-29T15:54:25+00:00July 19th, 2021|Categories: Clinical Trial, Europe, Regulatory, UK|Tags: Clinical Trial, Europe, MHRA, UK|
The Medicines and Healthcare products Regulatory Agency (MHRA) plans to streamline the review process for clinical trials of medicinal products concerning the changes brought by Brexit. As of January 2022, new Clinical Trials of Investigational Medicinal Products (CTIMPs) will [...]
k.janecek2024-02-26T16:46:14+00:00July 1st, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: Eudamed, Europe, European Commission, European Union, MDCG, Regulatory|
The European Commission’s Medical Device Coordination Group (MDCG) last week published a new guidance with Q&A on obligations and related rules for the registration in EUDAMED of actors not subject to registration requirements under the Art. 31 Medical Device [...]
k.janecek2024-02-29T15:05:43+00:00June 18th, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: Clinical Trial, Eudamed, Europe, IVDR, MDR, Regulatory|
The Medical Device Regulation (MDR) and the In vitro Diagnostic Medical Device Regulation (IVDR) were published in Turkish Official Gazette No. 31499 on 2 June 2021. The Regulation, which is fully harmonized with European Union legislation, aims to improve [...]
adminMTE_04792023-03-31T09:04:26+00:00May 6th, 2021|Categories: Europe, MDR, Regulatory|Tags: Clinical Trial, Europe, Germany, MDR, Regulatory|
The medical device regulation EU 2017/745 allows Member States some adjustments for local implementation. If you sponsor a trial in Germany, you must learn what are the new ordinances and guidelines for the implementation of the MDR. [...]
adminMTE_04792024-02-29T16:33:44+00:00May 5th, 2021|Categories: Europe, MDR, Regulatory|Tags: Clinical Trial, Europe, MDR, Regulatory|
WHY WE MUST UPDATE OUR TRIALS If you sponsor a trial that is already ongoing, you must update your safety procedures in accordance with the MDR by the deadline of May 26, 2021. If you are just [...]
adminMTE_04792023-03-31T12:43:00+00:00March 31st, 2021|Categories: Clinical Trial, Compliance, Regulatory|Tags: Clinical Trial, ICH, International Council for Harmonisation, Regulatory|
The International Council for Harmonisation (ICH) is working on the revision of E6 (R2) Good Clinical Practice, the guidace addressing GCP to provide a unified standard for the ICH region and to facilitate the mutual acceptance of clinical data. Meditrial [...]
adminMTE_04792023-03-31T13:15:38+00:00March 1st, 2021|Categories: Europe, Regulatory|Tags: Eudamed, Europe, MDCG|
The MDCG issued a new guidance "to Member States and other relevant parties on the application of certain MDR provisions during the absence of EUDAMED. To that end, this guidance intends to describe harmonised administrative practices and alternative technical solutions [...]
adminMTE_04792023-04-21T10:48:30+00:00January 29th, 2021|Categories: Regulatory, USA|Tags: ASCA, CDRH, Conformity Assessment, FDA, USA|
The US Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) annouced the full launch of a pilot conformity assessment program in 2021. Contact Meditrial to know about our strategic assessments of regulatory requirements to address business [...]
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