Issue 21: Pharmaceutical regulatory roundup

BY DR TIM SANDLE  | 30 May 2024



Catch up with the latest news from around the pharmaceutical industry with issue 21 of our regulatory review, curated by Dr Tim Sandle.


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Promotional communications for prescription biologics


The U.S. FDA has announced a revised draft guidance to address questions biologics companies may have when developing promotional communications for prescription biologics including reference products, biosimilars, and interchangeable biosimilars.


“Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers,” discusses considerations for presenting data about reference or biosimilar products in promotional communications to help ensure they are accurate and non-misleading.


This revised draft guidance fulfils the Biosimilar User Fee Amendments of 2022 commitment to publish draft guidance on promotional labelling and advertising considerations for interchangeable biosimilar products and replaces the 2020 draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products: Questions and Answers.”


Changes from the 2020 draft guidance include additional recommendations, an example of an interchangeable biosimilar product and the clarification of editorial changes.


For details, see: 




MHRA on the regulation of pharmaceutical products made using AI


Where Artificial Intelligence (AI) is used for a medical purpose, it is very likely to fall within the definition of a general medical device. This means that it must meet the requirements of the UK Medical Devices Regulations 2002 (as amended) to be on the market in the UK.


The MHRA is currently undertaking a programme of regulatory reform for medical devices. This includes ensuring there is proportionate regulation which takes into account the risks of these products without stifling the potential they have to transform healthcare.


The MHRA has issued a guidance document, dated April 2024, that addresses:


  • Safety, security and robustness: AI systems should function in a robust, secure and safe way throughout the AI life cycle. Risks should be continually identified, assessed and managed.
  • Appropriate transparency and explainability: AI systems should be appropriately transparent and explainable.
  • Fairness: AI systems should not undermine the legal rights of individuals or organisations, discriminate unfairly against individuals, or create unfair market outcomes.
  • Accountability and governance: Governance measures should be in place to ensure effective oversight of the supply and use of AI systems, with clear lines of accountability established across the AI life cycle.
  • Contestability and redress: Where appropriate, users, impacted third parties and actors in the AI life cycle should be able to contest an AI decision or outcome that is harmful or creates material risk of harm.


The paper is titled “Impact of AI on the regulation of medical products” and it can be found here: 




Inhalation and oral products


To help to further product quality and to protect patient safety, the European Medicines Agency (EMA) has issued a new draft guideline titled “Guideline on the pharmaceutical quality of inhalation and nasal medicinal products”. The draft seeks to replace the 2006 edition of the guidance and includes supplementary questions and answers posted on the EMA website. A companion document - “Guideline on the Requirements for Clinical Documentation for Orally Inhaled Products” remains current.


To access, see: 




Herbal monographs


The EMA has updated the “Template for Assessment report for the development of European Union herbal monographs and European Union list entries.” 


To review, see: 



Residual solvents


ICH guideline Q3C (R9) “Guideline on Impurities: Guideline for Residual Solvents” has been updated. The update is for consideration of solvent volatility for analytical methods (section 3.4., page 4).


The revised guidance came into effect on 29th April 2024.






PH. Eur. Supplement now available online


The European Pharmacopoeia (Ph. Eur.) Supplement 11.5 is now available. New monographs in Supplement 11.5 include cannabis flower and cannabidiol.






Maximum Residue Limit (MRL) evaluation for biological substances


The EMA has issued a new guidance, effective from August 2024, titled “Guideline on determination of the need for an MRL evaluation for chemical-unlike biological substances”.


Biological substances are a heterogeneous group of compounds used as active ingredients in veterinary medicinal products. According to Regulation (EU) 2019/6, they are substances that are produced by or extracted from a biological source. To determine their quality and characterisation, these substances need a combination of physicochemical-biological testing, together with knowledge of the production process and its control.


Based on their specific nature, the standard assessments currently used for MRL and 
consumer safety do not always adequately match data needs and assessment requirements for biological substances.


The new guidance seeks to address this: 


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