All Regulatory Rapporteur articles in January 2025
View all stories from this issue.
-
JournalThe role of artificial intelligence in regulatory affairs
This article explores the enormous potential of artificial intelligence (AI) technologies in regulatory affairs, highlighting how AI can streamline regulatory compliance, expedite submissions, enhance predictive analytics for decision-making, improve pharmacovigilance and elevate regulatory intelligence when properly applied. The discussion covers not only the advantages of AI but also the complexities of integrating AI into regulatory affairs, such as the challenges of algorithm interpretability, data quality, regulatory compliance, fairness, security, privacy and model accuracy. Additionally, it emphasises the collaborative efforts of the global regulatory community in developing guidelines and frameworks for the safe and effective use of AI.
-
JournalOverview of chemical generics registration in China: Challenges for overseas applicants
This is the fifth article in a six-part series that focuses on the regulations in China’s drug market. There will be different topics each month with the initial focus on the drug master file (DMF) filing process followed by the drug registration process and pharmacovigilance requirements.
-
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).
-
JournalConsiderations in the development of allogenic and autologous cell therapies
Autologous cell therapy involves the use of a patient’s own cells which are harvested, modified or expanded ex vivo and then reintroduced into the patient. Allogeneic therapies use cells from a donor modified or expanded ex vivo and then administered to the patient.
-
JournalUnique aspects of biologic reference standards
Reference standards are pivotal in ensuring pharmaceutical quality, especially for complex biologics. This article reviews definitions and classifications of reference standards as outlined by the US Food and Drug Administration (FDA), the World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q6B and Q7 guidelines. It addresses types of standards based on source and use, with particular emphasis on the distinct requirements for biologics.
-
JournalConsiderations for generics developers moving into the field of biosimilars
Many generic developers have experience in both manufacturing and gaining US and EU approval for generics which are small molecule alternatives to the authorised original products. These developers possess the relevant skillsets to allow them to pursue the development of biosimilars, which are large molecule biologics highly similar to the authorised original products.
-
-
