Jordan Draft Framework for Pharmaceutical Product Licensing and Regulatory Compliance
Jordan has issued draft instructions for the licensing, registration, import, distribution, and post-market oversight of pharmaceutical and cosmetic products. The framework also strengthens requirements for GMP, traceability, labeling, inspections, and market authorization compliance.
JFDA | Pharmaceuticals | Regulatory AffairsStatistical Approaches to Establishing Bioequivalence
FDA guidance providing recommendations to sponsors/applicants using equivalence criteria in analyzing in vivo or in vitro bioequivalence studies for INDs, NDAs, ANDAs, and supplements. Discusses average, population, and individual BE approaches to compare bioavailability measures
USFDA | Pharmaceuticals | Regulatory AffairsBioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA)
FDA guidance providing recommendations to applicants planning to include bioequivalence (BE) information in ANDAs and ANDA supplements. It describes how to meet BE requirements in FDA regulations for oral and non-oral dosage forms. This guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs), ANDA amendments, and ANDA supplements.
USFDA | Pharmaceuticals | Regulatory AffairsEnhanced Import Authorization and Compliance Requirements for Pharmaceutical Products
EDA has updated its import and customs clearance framework for pharmaceuticals, introducing enhanced approval processes, stricter compliance requirements, and strengthened oversight of GMP, supplier qualification, and import controls.
Egyptian Drug Authority (EDA) | Pharmaceuticals | Regulatory AffairsMalaysia NPRA Updates FAQ on Electronic Labelling (E-Labelling) Implementation for Pharmaceutical Products
Enhanced Import Authorization and Compliance Requirements for Pharmaceutical Products
NPRA | Pharmaceuticals | Regulatory Affairs
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