Digital leaflets

The pharmaceutical industry is a highly regulated sector, with various agencies and organizations worldwide working to ensure the safety, efficacy, and quality of medicines. As of August 2024, significant updates have emerged from various regulatory bodies, including the ISPE Regulatory Quality Harmonization Committee (RQHC), the European Medicines Agency (EMA), Brazil’s ANVISA, Mexico’s COFEPRIS, and the U.S. FDA. This article provides an in-depth exploration of recent developments in pharmaceutical regulations across different regions.

In April 2024, the European Parliament approved new pharmaceutical legislation aimed at enhancing patient access to innovative medicines while ensuring high safety standards. This legislation is expected to facilitate the availability of new therapies and streamline approval processes.

On June 17, 2024, the European Commission published a new variations regulation set to take effect on January 1, 2025. This regulation will introduce updated guidelines for variations to marketing authorizations, with a draft guideline expected to follow within three months.

The European Commission has updated its guidelines regarding phthalates in medical devices. The revisions focus on the benefit-risk assessment of CMR (Carcinogenic, Mutagenic, or Reproductive toxic) and endocrine-disrupting phthalates. Additional annexes detail advancements in understanding alternatives to phthalate plasticizers over the last five years.

The final text of the Artificial Intelligence Act was published in June 2024, establishing a legal framework for promoting “human-centric and trustworthy” AI applications in medical devices. The act sets harmonized rules for market placement and introduces specific requirements for high-risk AI systems, effective from August 2, 2026.

The EMA has released guidance aimed at maintaining a continuous supply of medicines within the EU single market. This includes templates for Medicine Shortage Prevention Plans (SPP) and Mitigation Plans (SMP). The European Shortages Monitoring Platform (ESMP) is expected to go live in February 2025.

On September 10, 2024, ANVISA will launch a pilot project allowing digital leaflets to replace printed medication leaflets for specific products. This initiative aims to create an electronic product information repository (ePIR) accessible via QR codes on medicine packages.

ANVISA has revoked previous traceability regulations through RDC 886/2024, aligning with Law 14 338 established in May 2022 that allows distribution maps to suffice for drug traceability.

Normative Instruction (IN) 292/2024 outlines criteria for defining Equivalent Foreign Regulatory Authorities (EFRA) for GMP inspections of APIs and cannabis products. This regulation aims to streamline GMP certification processes by recognizing various levels of regulatory confidence.

RDC 876/2024 revises requirements concerning quality changes for biological products, reducing the need for individual submissions in cases of simultaneous quality changes.

ANVISA released Guide 72/2024 detailing validation criteria for bioanalytical methods used in regulatory submissions for industrialized medicinal products.

COFEPRIS has introduced a new template for variations to marketing authorization conditions as part of its ongoing efforts to streamline regulatory processes. The agency is also undergoing structural changes under new leadership.

The FDA has issued exemptions under DSCSA until November 27, 2026, allowing small dispensers additional time to stabilize their operations while complying with enhanced drug distribution security requirements.

The FDA published final guidance outlining behaviors that constitute delaying or denying drug inspections under section 501(j) of the Federal Food Drug & Cosmetic Act. This guidance clarifies expectations during inspections and aims to improve compliance.

A new FDA guidance titled “Container Closure System and Component Changes: Glass Vials and Stoppers” provides recommendations regarding reporting changes to container closure systems for sterile drug products.

During the ICH Assembly meeting held in June 2024 in Fukuoka, Japan:

• New members joined ICH, including ANMAT from Argentina and JFDA from Jordan.
• The assembly endorsed new topics for harmonization related to mutagenic impurities and real-world data use.
• ICMRA’s PQKM pilot programs completed their initial phase focusing on collaborative quality assessments and inspections.

The U.S. FDA, Health Canada, and UK MHRA jointly issued guiding principles aimed at fostering international harmonization concerning transparency throughout the life cycle of machine learning-enabled medical devices.

The pharmaceutical regulatory landscape is continuously evolving as agencies worldwide adapt to new challenges and opportunities. The updates from August 2024 reflect a commitment to improving patient access to safe and effective medicines while ensuring rigorous safety standards are maintained.As stakeholders navigate these changes, staying informed about regulatory developments will be crucial for ensuring compliance and fostering innovation within the industry.