Small and Medium-sized Enterprises (SMEs) Highlights

• A revised ICH E2D(R1) guideline on ‘Post-approval safety data: definitions and standards for management and reporting of individual case safety reports’, updated on the use of new sources of post-approval safety information such as social media, market research and patient support programs; until 22 June 2024.
• A revised guideline on Good Agricultural and Collection Practice for starting materials of herbal origin, updated to consider advances such as indoor growing technologies, established practices and legal interpretations; until 15 July 2024 (herbal medicines).
• A draft guideline providing guidance on stability data to be generated to support a variation to a marketing authorisation for veterinary medicinal products; until 31 August 2024.
• A revised guideline on requirements for demonstrating therapeutic equivalence between orally inhaled products for asthma and chronic obstructive pulmonary disease, updated on conditions for accepting in vitro data for therapeutic equivalence, paediatric requirements and pharmacokinetics data extrapolation; until 30 October 2024.
• A revised guideline on the pharmaceutical quality of inhalation and nasal human medicinal products, updated to consolidate guidance previously provided in a questions & answers document, advances in the field and the medical device regulation; until 31 October 2024.

• A new guideline for quantitative evidence synthesis on direct and indirect comparisons published by the Member State Coordination Group on health technology assessment (HTACG). It describes the methods currently available for direct and indirect treatment comparisons regarding the underlying assumptions, strengths and weaknesses in the context of joint clinical assessment of health technologies.
• A revised guideline ICH Q3C (R9) on ‘Impurities/Residual solvents’, updated on solvent volatility for analytical methods; came into effect on 29 April 2024.
• A new guideline on data requirements and rules for the determination of the need for a Maximum Residue Limit evaluation for chemical-unlike biological non-immunological substances used in veterinary medicinal products intended for use in food-producing species; will come into effect on 1 August 2024.
• A revised guideline on plasmid DNA vaccines for veterinary use addressing quality, safety and efficacy aspects of nucleic acid vaccines for use in animals; will come into effect on 17 July 2024. The update includes alignment with Regulation (EU) 2019/6 and additional clarifications resulting from experience gained from centrally authorised veterinary DNA vaccines.
• A revised guideline on environmental risk assessment (ERA) of human medicinal products, updated with guidance on risk and hazard assessment, reporting of findings and requirements for marketing authorisations; will come into effect on 1 September 2024.
• Questions and Answers on EU Good Manufacturing Practices and Good Distribution Practice updated on aspects related to manufacturing of sterile medicinal products and sampling of starting and packaging materials for human and veterinary medicines. 

• Harmonised scientific advice to support the submission of marketing authorisation and clinical trial applications (CTAs) in the EU
• Consolidated technical/regulatory advice on CTA dossiers prior to their submission in CTIS.

Learnings from the pilots will be used to consolidate and streamline scientific advice on clinical trials. More information on the pilots will be available in due course on the ACT EU website.

The catalogue of RWD sources replaces the ENCePP Resources Database and the one of RWD studies replaces the EU PAS Register.

Please see more information here.

It highlights how stakeholders and partners can request real-world data studies from EMA, the types of studies that can be performed and how EMA can help identify resources to address research questions (see document).

A reflection paper on non-interventional studies methodologies using real-world data (RWD) to generate real-world evidence (RWE) for regulatory purposes has been released for consultation until 31 August 2024. The paper will be discussed in a dedicated session at the multi-stakeholder joint HMA-EMA workshop on RWE methods on 14 June 2024.

Paediatric submissions in IRIS

From 4 June 2024, paediatric submissions such as paediatric investigation plans, waivers or deferrals will have to be made via the IRIS platform (see webpage). More information and guidance on IRIS is available in a specific section in the IRIS website. Applicants can also refer to a video recording of the EMA Quarterly System Demo. 

Commercially confidential information and personal data

An EMA/HMA guidance document on how to identify and handle commercially confidential information and personal data in documents relating to human marketing authorisation applications and post-authorisation activities, that are subject to access to documents requests and publication in accordance with Regulation (EC) No. 1049/2001 or National legislations, has been released for public consultation until 28 June 2024.

Marketing authorisation transfer

Veterinary marketing authorisation holders will now benefit from a simplified transfer procedure, with new templates and a reduced number of supporting documentation. Updated questions and answers are available on the EMA website.

Abbreviations, pictograms and small packaging

As part of the implementation of Veterinary Medicines Regulation (EU) 2019/6, the European Commission adopted Regulation (EU) 2024/875 that allows changes of the information on the immediate and outer packaging for existing and new veterinary products with the approved abbreviations and pictograms listed in this Regulation. The regulation applies from 11 May 2024.

• Product Management Service (PMS) Product UI and API training (access & navigation)
  
• Multi-stakeholder webinar on the HMA-EMA catalogues of real-world data sources and studies
• CTIS walk-in clinic
• Orphan medicines developments - ask the European regulator
• Multi-stakeholder workshop on data quality framework for adverse drug reaction reporting
• EMA and European Organisation for Research and Treatment of Cancer (EORTC) workshop: How can PRO and HRqoL data inform regulatory decisions
• Technical webinar Regulatory Procedure Management for product lifecycle management (PLM) in IRIS for Network Users
• Update webinar on regulatory procedure management for product lifecycle management in IRIS
• Network users training for regulatory procedure Management 1st roll-out on IRIS
• Webinar on simultaneous national scientific advice
• EU NTC ten-year anniversary event
• Information and Q&A session on updated CAPs in web-based eAF
• Meeting report - Joint EMA/EORTC workshop on soft tissue and bone sarcoma
• Report of ACT EU methodology guidance workshop