All Marketing authorisation application (MAA) articles
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Industry newsEMA launches new pre-submission interactions model pilot
Beginning in September 2026, the European Medicines Agency (EMA) has invited marketing authorisation applicants to participate in an 18-month pre-submission interactions (PSI) model pilot.
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JournalDeciphering the regulatory landscape of MENA markets: Challenges in pricing and ancillary issues
The pharmaceutical market in the Middle East and North Africa (MENA) region is growing rapidly, offering vast opportunities for innovation and market expansion. However, navigating the regulatory landscape in this diverse and complex region presents unique challenges that pharmaceutical companies must address in order to create a value proposition.
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JournalAddressing the challenges of implementing the common technical document in Brazil
The common technical document (CTD) is the standard format for regulatory dossiers. It was developed in early 2000 for use in Europe, the United States (US) and Japan, and is currently accepted in several other regions such as Australia, Canada, India, South Africa, Switzerland and, since August 2019, Brazil, with the publication of Guide N°24/2019 from the Brazilian Health Regulatory Agency (Anvisa).
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JournalNew data protection for maximum residue limits
Regulatory Rapporteur March 2024 | Volume 21 | No.3 Abstract Maximum residue limits (MRL) have been a requirement for all substances included in veterinary medicines intended for food-producing animals since the 1990s. The new Veterinary Medicines Regulation ([EU] 2019/6) ...
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JournalCell and gene therapy – navigating complexities in CMC development for optimisation of global regulatory strategies
Cell and gene therapy (CGT) products represent a frontier in modern medicine, offering precision treatments. Yet their development is affected by multifaceted challenges including chemistry, manufacturing, and controls (CMC). This article provides a comprehensive exploration of the complexities involved in CMC development and considers its role in establishing quality, safety ...