FDA INTERACT Meetings: Early Strategic Alignment for Innovative Therapies
At Global Regulatory Partners (GRP), we understand that early regulatory strategy plays a critical role in the success of innovative drug development programs. For companies developing novel therapies—especially those with limited regulatory precedent—the FDA’s INTERACT meeting represents a valuable opportunity to engage with the Agency at a formative stage.
INTERACT (Initial Targeted Engagement for Regulatory Advice on CBER- and CDER-Regulated Products) is designed to support early, focused dialogue between sponsors and FDA reviewers. When strategically utilized, it helps identify potential risks, refine development strategies, and establish a solid regulatory foundation before significant investments are made.
The Future of Digital Health: ANVISA and the New Era of AI in Software as a Medical Device (SaMD)
This Blog details the revision of RDC No. 657/2022 by ANVISA, driven by the rise of Generative AI. We discuss how new risk classification criteria impact the development of software that diagnoses and suggests treatments, ensuring patient safety without stifling innovation.
Brazil and Mexico: A New Era of Sanitary Integration and Innovation in Latin America
This article explores the recent strengthening of bilateral cooperation between the regulatory agencies of Brazil and Mexico. The central focus is the harmonization of standards to accelerate the registration of medicines and medical devices, while fostering regional biotech innovation hubs.
Strengthening Innovation and Compliance Across Pharma, Medical China Regulatory and Cosmetics
China continues to advance its life sciences regulatory framework with a strong emphasis on balancing innovation and regulatory oversight. Recent updates issued by the National Medical Products Administration (NMPA) and the Center for Drug Evaluation (CDE) introduce new clinical evaluation guidance for pharmaceuticals and enhanced technical standards for cosmetic ingredients. These measures signal a continued shift toward life cycle-based regulation, scientific consistency, and higher quality standards across regulated products.
Strengthening Innovation and Compliance Across Pharma, Medical China Regulatory and Cosmetics
China’s National Medical Products Administration (NMPA) has introduced major regulatory updates across pharmaceuticals, medical devices, and cosmetics, emphasizing innovation, lifecycle supervision, and strengthened technical standards. These changes reflect China’s push toward a more predictable, science‑driven regulatory environment that supports development while reinforcing compliance.
EMA Guidance on GMP Considerations for Additive Manufacturing of Solid Oral Dosage Forms
The European Medicines Agency (EMA) has issued guidance addressing Good Manufacturing Practice (GMP) considerations for the use of additive manufacturing, also known as 3D printing (3DP), in the production of solid oral dosage forms. This guidance represents a significant step toward integrating innovative manufacturing technologies into the pharmaceutical regulatory framework while ensuring product quality, safety, and efficacy.