Action required: Consultation for the EMA PRIority MEdicine (PRIME) draft toolbox guidance closes 31st July 2021.

What is PRIME about?

The European Medicines Agency (EMA) launched the PRIority MEdicines (PRIME) scheme in March 2016. The scheme was launched to provide early and enhanced scientific and regulatory support for medicines that target an unmet medical need. PRIME focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without any treatment options.

PRIME benefits

PRIME aims to bring promising innovative medicines to patients faster by optimising and supporting medicine development. PRIME benefits patients, but also the industry.

Benefit for patients:

  • PRIME is driven by patients’ needs
  • PRIME focuses on medicines to address unmet needs and rare diseases
  • PRIME helps to translate research into development while meeting regulatory requirements
  • PRIME brings promising treatment to patients earlier

Benefit for industry

  • PRIME assists development of promising medicines
  • PRIME fosters early dialog with the EMA to facilitate robust data collection
  • PRIME supports creation of high-quality Marketing Authorisation Applications
  • PRIME aims to speed up the evaluation process
  • PRIME encourages developers to focus on medicines that are likely to make a real difference

Challenges:

Experience to date has shown that applicants face challenges to complete quality, manufacturing development and data requirements during development of medicines for early access. Initiatives such as the ‘rolling review’ are trying to address such challenges for promising or urgently required medicines.

How does the PRIME process work?

Data from the EMA shows that only just over 20% of PRIME requests are actually granted. However, once a candidate medicine has been selected, the Agency:

  • appoints a rapporteur from the Committee for Medicinal Products for Human Use (CHMP) or from the Committee for Advanced Therapies (CAT), to provide continuous support and help to build knowledge ahead of Marketing Authorisation Application (MAA);
  • organises a kick-off meeting with the CHMP/CAT rapporteur and a multidisciplinary group of experts from relevant EMA scientific committees and working parties;
  • issues guidance on a company’s overall development plan and regulatory strategy;
  • offers a dedicated EMA contact person;
  • provides scientific advice at key development milestones, involving additional stakeholders as needed.

It is important to note that medicinal products eligible for PRIME are potentially eligible for accelerated assessment during the Marketing Application process, a benefit not to be underestimated.

EMA’s PRIME toolbox

Until 31/July/2021 the EMA is now looking for feedback on their PRIME toolbox (reference EMA/CHMP/BWP/QWP/IWG/694114/2019, 02/February/2021). Consultation is sought on this ‘toolbox style’ document that provides guidance by summarising scientific elements and regulatory tools, available in the existing EU regulatory framework. It is seen as support for the development and completion specifically of Module 3 quality data packages in the preparation of MAAs. It is hoped, that a well-prepared Module 3 will support timely access to the medicine whilst providing assurance that product quality, efficacy and safety are not compromised.

The document includes two major sections:

Scientific tools

Referring to scientific concepts, principles or technologies used for development, manufacture and quality risk management of medicinal products. These might include modelling, analytical or platform technologies.

Regulatory tools

The EMA seeks to support the medicinal product development process early on and to offer regulatory mechanisms to help a ‘faster time to market’ approach without compromising quality, safety or efficacy. This process for example includes giving scientific advice during medicinal product development.

In summary

EMA’s ‘PRIME toolbox’ document outlines the available support from the Agency with scientific and regulatory tools, easing the way for the industry to be able to gain quicker market access for medicinal products addressing unmet medical needs. Action is required as comments are required by 31/July/2021.

Published by Olaf Schoepke

Passionate about sharing ideas with regulatory professionals in the human and veterinary medicinal product space.

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