Search and filter

The Access Consortium is a collaboration of five national regulatory agencies (MHRA, TGA, Health Canada, HSA, and Swissmedic) that work together to align regulatory processes and reduce duplication in drug evaluations. Its purpose is to enhance international cooperation, ensuring timely access to high-quality, safe, and effective therapeutic products across member countries.

Within the European Union (EU), individual member states possess national competent authorities responsible for medicine regulation. These national bodies collaborate with the European Medicines Agency (EMA), which undertakes a primary assessment and coordination function across the EU. Pharmaceutical companies have several routes for obtaining a marketing authorisation (MA), influenced by market scope and product characteristics: national authorisation, mutual recognition (MRP), decentralised (DCP), and centralised EU authorisation.

The Innovative Licensing and Access Pathway (ILAP) is a regulatory initiative led by the MHRA, designed to accelerate the development and approval of innovative medicines. It involves collaboration with the national health technology assessment bodies to coordinate the regulatory approval with technology assessment and allow faster patient access to new innovative treatments.

The National Agency for the Safety of Medicines and Health Products (Agence Nationale de Sécurité du Médicament et des Produits de Santé, ANSM) is the French national authority responsible for ensuring the safety, efficacy, and quality of health products, including medicines, medical devices, and other health-related products. Working closely with the European Medicines Agency (EMA) and operating under the Ministry of Health, the ANSM oversees the entire lifecycle of these products, from development through to post-market surveillance.

A Marketing Authorisation (MA) confirms that a regulatory authority, such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), has evaluated a medicinal product and permits its marketing. The assessment verifies adequate quality, safety, and efficacy for the specified use, based on a positive benefit-risk determination. While procedures differ, key stages are common across major agencies.

The MHRA's 150-day assessment process is an expedited pathway for evaluating national marketing authorisation applications for medicines. This streamlined process aims to accelerate patient access to safe and effective medicines by reducing the standard assessment timeline while maintaining rigorous regulatory standards.

The MHRA's international recognition procedure enables medicines that have been approved by trusted regulatory authorities — such as the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA) — to receive authorisation in the UK through a streamlined process that acknowledges these prior assessments.

The Medicines and Healthcare products Regulatory Agency (MHRA) offers a comprehensive service for pharmaceutical companies seeking scientific advice during the development of their products. This guidance is intended to help companies optimise their development process and ensure compliance with regulatory requirements.

Project Orbis is a global regulatory programme led by the US FDA, designed to speed up the review and approval of promising cancer drugs through collaboration among international regulatory authorities. It enables faster patient access to innovative oncology treatments by allowing for concurrent submission, review, and potential approval across multiple countries.

The Simultaneous National Scientific Advice (SNSA) pilot project is an initiative by the European Union (EU) Innovation Network aimed at enhancing the efficiency and consistency of scientific advice for pharmaceutical development. It enables developers to obtain coordinated national scientific advice from multiple National Competent Authorities (NCAs) concurrently, streamlining the advisory process and fostering alignment among regulatory bodies.

Why a good working understanding of the regulatory approval process is invaluable to the access practitioner.