"What" Series

What is the difference between EMA and HMA?

17 April 2024
2 min read

EMA (European Medicines Agency) and HMA (Heads of Medicines Agencies) are two distinct organizations that play vital roles in the regulation of medicinal products, but their functions and scopes differ.

EMA (European Medicines Agency): The EMA is the regulatory body for medicines within the European Union (EU), responsible for coordinating and supervising the assessment, authorization, and monitoring of medicines across EU member states. It handles the Centralized Procedure, through which approved drugs can be marketed in all EU member states as well as in Iceland, Liechtenstein, and Norway. The EMA also provides scientific advice and guidance to ensure the quality, safety, and efficacy of medicines.

The official EMA website (https://www.ema.europa.eu/) offers detailed information on drug assessments, approval processes, guidelines, clinical trial databases, and more.

HMA (Heads of Medicines Agencies): The HMA is an international organization comprising the heads of national medicinal regulatory agencies from both European and non-European countries. Its purpose is to foster cooperation and coordination among member states' regulatory bodies, share best practices and experiences, and enhance the consistency and efficiency of global medicinal product regulation. HMA membership includes the EMA as well as national regulatory agencies from around the world, such as the FDA (Food and Drug Administration) of the USA and Health Canada. The HMA promotes coordination and standardization of global medicinal product regulation through meetings, working groups, and collaborative projects.

In summary, the EMA is the medicinal regulatory body within the EU, while the HMA is a broader international collaboration organization aimed at strengthening cooperation among global medicinal regulatory bodies. Both are committed to ensuring the safety and efficacy of medications, but their working scopes and collaboration models differ.

图形用户界面, 文本, 应用程序, 聊天或短信

描述已自动生成

Pharma Frontiers: Daily Digest of Global Pharmaceutical News - April 17
Pharma Frontiers
10 min read
Pharma Frontiers: Daily Digest of Global Pharmaceutical News - April 17
17 April 2024
April 17th latest updates in the global new drug development field, including progress in new drug research and development, transaction information, and partnership developments.
Read →
Arvinas and Novartis Seal Global Licensing Deal for Prostate Cancer Therapy ARV-766
Latest Hotspot
3 min read
Arvinas and Novartis Seal Global Licensing Deal for Prostate Cancer Therapy ARV-766
16 April 2024
Arvinas has initiated a deal with Novartis that encompasses a worldwide licensing pact to advance and market their PROTAC® technology-based AR degrader ARV-766, aimed at prostate cancer therapies.
Read →
How to search for global clinical trial information on drugs?
Knowledge Base
3 min read
How to search for global clinical trial information on drugs?
16 April 2024
Information on ongoing clinical drug trials worldwide can be accessed through the several channels.
Read →
Alpine Immune Sciences Unveils Latest Trial Results for Povetacicept Treating IgA Kidney Disease
Latest Hotspot
4 min read
Alpine Immune Sciences Unveils Latest Trial Results for Povetacicept Treating IgA Kidney Disease
16 April 2024
Alpine Immune Sciences Reports New Clinical Data for Povetacicept in IgA Nephropathy.
Read →
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.