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1. www.ema.europa.eu › en › clinical-investigation-medicinal-products-treatment-orClinical investigation of - European Medicines Agency (EMA)

   www.ema.europa.eu › en › clinical-investigation-medicinal-products-treatment-or

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   1 sty 2024 · This document provides guidance on clinical development programmes intended to support the registration of new medicinal products for the treatment of diabetes mellitus. It also addresses the development of products to delay in onset or prevention of diabetes mellitus or preservation of beta-cell function in patients with diabetes.

   • Guideline on clinical inviestigation of medicinal products in the ...

     Indeed, it has been shown that normalisation or near...

   • Guideline on clinical investigation of medicinal products in the ...

     622 Therapeutic confirmatory studies should assess the...

2. www.ema.europa.eu › en › documentsGuideline on clinical inviestigation of medicinal products in the...

   www.ema.europa.eu › en › documents

   Indeed, it has been shown that normalisation or near normalisation of glucose levels (assessed by changes in HbA1c) in patients with type 1 and type 2 diabetes significantly reduces the risk of microvascular complications (retinopathy, nephropathy, and neuropathy).

3. www.ema.europa.eu › en › documentsGuideline on clinical investigation of medicinal products in the...

   www.ema.europa.eu › en › documents

   622 Therapeutic confirmatory studies should assess the safety and efficacy of the insulin preparation in 623 type 1 and type 2 diabetes. Patients should be treated to glycaemic target taking into account limiting 624 adverse effects, particularly hypoglycaemia.

4. link.springer.com › article › 10New guideline of the European Medicines Agency (EMA) on the ... -...

   link.springer.com › article › 10

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   4 maj 2024 · The European Medicines Agency (EMA)’s revised guideline on the clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus took effect on 1 January 2024, replacing the previous guideline from 2012 [1, 2].

5. pubmed.ncbi.nlm.nih.gov › 38702529New guideline of the European Medicines Agency (EMA) on the ... -...

   pubmed.ncbi.nlm.nih.gov › 38702529

   New guideline of the European Medicines Agency (EMA) on the clinical investigation of medicinal products in the treatment and prevention of diabetes mellitus. Diabetologia. 2024 Jul;67 (7):1159-1162. doi: 10.1007/s00125-024-06162-z. Epub 2024 May 4.

6. health.ec.europa.eu › medicinal-products › eudralexEudraLex - Volume 4 - European Commission - Public Health

   health.ec.europa.eu › medicinal-products › eudralex

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   8 paź 2003 · Part IV - GMP requirements for Advanced Therapy Medicinal Products. Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products; Other documents related to GMP and GDP. Compilation of Union Procedures on Inspections and Exchange of Information

7. www.ncbi.nlm.nih.gov › pmc › articlesThe European Medicines Agency's approval of new medicines for...

   www.ncbi.nlm.nih.gov › pmc › articles

   30 maj 2018 · Recognizing the importance of this disease, the approval of human medicines containing a new active substance for the treatment of diabetes in the EU was made compulsory by European legislation in 2005 via one single, centralized application procedure at the European Medicines Agency (EMA).