Trusted Resource for Clinical Trials, Protocols & Progress
Knowing what type of inspection your facility may undergo helps with preparation, resource allocation, and risk mitigation. Regulatory readiness is not a one-size-fits-all solution—each inspection type comes with specific expectations, documentation requirements, and focus areas.
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Comprising ten member states, ASEAN aims to enhance regional collaboration in pharmaceuticals and medical product regulation. Through initiatives like the ASEAN Common Technical Requirements (ACTR) and ASEAN Common Technical Dossier (ACTD), the organization standardizes clinical trial conduct, marketing authorization submissions, and Good Manufacturing Practices (GMP) across the region, improving efficiency and consistency.
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EMA inspections are part of a harmonized regulatory framework designed to ensure the quality, safety, and efficacy of medicinal products authorized for use in the EU. These inspections are carried out either directly by the EMA or by national competent authorities (NCAs) of EU member states under EMA coordination.
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EMA inspections ensure that pharmaceutical manufacturers, sponsors, and clinical trial sites adhere to applicable EU legislation. These inspections are essential for:
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Health Canada regulates pharmaceuticals, biologics, natural health products, and medical devices through a structured framework aligned with international standards such as ICH-GCP. It offers clear pathways for clinical trial authorization, new drug submissions, expedited programs for unmet medical needs, and comprehensive post-market obligations, providing a supportive environment for innovation and patient access.
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The FDA defines a combination product as a therapeutic and diagnostic product that combines any two or more of the following:
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A waiver means exemption from conducting Phase III (or bridging) clinical trials in the Indian population before granting marketing approval for a new drug. This is often applicable for drugs already approved and marketed in certain regulated countries.
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The IND is a comprehensive document that provides the FDA with all necessary data to evaluate whether a new drug is reasonably safe to move into human clinical trials. It bridges the gap between laboratory research and human testing, and its approval is mandatory before initiating any clinical study.
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A SUSAR is a serious adverse reaction to a medicinal product that is both unexpected (not consistent with the product’s Investigator’s Brochure or Summary of Product Characteristics) and suspected to be related to the investigational medicinal product. Reporting SUSARs promptly helps protect clinical trial subjects and ensures regulatory compliance.
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The Centralised Marketing Authorisation Procedure allows sponsors to submit one application, undergo a single scientific evaluation by the EMA’s Committee for Medicinal Products for Human Use (CHMP), and receive a binding decision from the European Commission (EC) valid in all EU and EEA countries. This harmonised process ensures consistency in drug approval, especially for innovative and high-impact medicinal products.
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