Pharmaguideline

Pharmaguideline

5/18/2025, 6:48:34 PM

https://www.pharmaguideline.com/2025/05/gemba-walks-implementation-in-pharmaceuticals.html

Pharmaguideline

6/9/2025, 12:49:18 AM

https://www.pharmaguideline.com/2025/05/top-4-problems-in-sterile-manufacturing.html?m=1

Pharmaguideline

2/1/2025, 12:06:01 PM

Here are the latest pharmaceutical regulatory updates: *EU Regulatory Updates* - *New Variations Regulation*: The EU Commission has published a new variations regulation, effective January 1, 2025 ¹. - *Draft EU Variation Classification Guideline*: A draft guideline is available for comments until August 23, 2024, and includes PLCM (Post-Launch Change Management) ¹. - *Guidance on Phthalates for Medical Devices*: The EU Commission has updated its guidance on phthalates, including new annexes on alternatives to phthalate plasticizers ¹. - *Artificial Intelligence Act*: The EU Commission has published the final text of the Artificial Intelligence Act, establishing a legal framework for AI in medical devices ¹. *FDA Regulatory Updates* - *Revised Nitrosamines Guidance*: The FDA has revised its guidance on controlling nitrosamine impurities in human drugs, including new information on nitrosamine drug substance-related impurities ¹. - *Digital Health and Artificial Intelligence Glossary*: The FDA has published a glossary of digital health and artificial intelligence terms to support consistent use of terminology ¹. - *Waivers and Exemptions*: The FDA has granted waivers and exemptions for certain trading partners, including manufacturers, repackagers, and wholesale distributors ¹. *ANVISA Regulatory Updates* - *Digital Leaflet and Exemption of Printed Leaflet*: ANVISA has introduced a pilot project allowing for the optional exemption of printed leaflets on medication packages ¹. - *Revocation of Traceability Regulations*: ANVISA has revoked all current traceability regulations in Brazil ¹. - *Optimized Procedure for GMP Certification*: ANVISA has established an optimized procedure for GMP certification, including reliance on equivalent foreign regulatory authorities.

Pharmaguideline

2/5/2025, 1:07:18 PM

Today's pharmaceutical industry is constantly evolving, with regular updates on regulations, guidelines, and new technologies. Here are some recent updates: *Regulatory Updates* - *New Variations Regulation*: The EU Commission has published a new variations regulation, effective January 1, 2025 ¹. - *Artificial Intelligence Act*: The EU Commission has published the final text of the Artificial Intelligence Act, which establishes a legal framework for the use of AI in medical devices ¹. - *Guidance on Phtalates for Medical Devices*: The EU Commission has updated its guidance on the benefit-risk assessment of phthalates in medical devices ¹. *Guideline Updates* - *EMA Guidance on Environmental Risk Assessment*: The European Medicines Agency (EMA) has updated its scientific guideline on environmental risk assessment of medicinal products for human use ¹. - *FDA Guidance on Nitrosamine Impurities*: The US Food and Drug Administration (FDA) has revised its guidance on controlling nitrosamine impurities in human drugs ¹. *Industry Developments* - *Use of AI in Pharmaceutical Development*: The EMA has published a reflection paper on the use of artificial intelligence in the medicinal product lifecycle ¹. - *Digital Health and Artificial Intelligence Glossary*: The FDA has published a digital health and artificial intelligence glossary to support consistent use of terminology ¹.

Pharmaguideline

2/11/2025, 10:24:29 AM

*FDA issues Draft Guidance on Handling Protocol Deviations in Clinical Trials* The FDA has issued a draft guidance that provides recommendations to help sponsors, investigators, and institutional review boards (IRBs) define, identify, and report protocol deviations in clinical trials. *Definitions for Protocol Deviations and Important Protocol Deviations* According to the agency, protocol deviations are generally unintentional departures from the IRB-approved protocol and are commonly not discovered until after they occur. A system for classifying the various types of deviations that may occur during the conduct of a clinical trial (including classification, reporting, and documentation standards) is important to assure the most interpretable and useful information emerges from the reporting of protocol deviations. To address these considerations, the draft guidance defines the following: *Protocol Deviations:* “Any change, divergence, or departure from the study design or procedures defined in the protocol” *Important Protocol Deviations:* “A subset of protocol deviations that might significantly affect the completeness, accuracy, and/or reliability of the study data or that might significantly affect a subject’s rights, safety, or well-being.” (ICH E3(R1)). All other protocol deviations that do not meet the definition of an important protocol deviation may encompass the commonly used terms minor, noncritical, and non-significant deviations. According to the guidance, the term protocol encompasses both written protocols and their related plans and procedures (e.g., monitoring plan, statistical analysis plan). Morover, the draft guidance includes recommendations on the Roles and Responsibilities in Monitoring, Mitigating, and Reporting Protocol Deviations (i.e., for sponsors, investigators and IRBs). More information is available in FDA's draft guidance document Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/protocol-deviations-clinical-investigations-drugs-biological-products-and-devices