Regulatory Guidelines

CDSCO Guidelines for Clinical Trials and Drug Approvals in India: A Complete Overview

May 2, 2025

As the regulatory arm of the Ministry of Health and Family Welfare, CDSCO ensures that drugs, biologics, and medical devices meet standards of safety, efficacy, and quality. With the introduction of the New Drugs and Clinical Trials Rules, 2019 (NDCTR), India has streamlined its clinical trial approval processes, aiming to align more closely with global standards while maintaining robust patient protections.
Click to read the full article.

CDSCO (India) Guidelines, Regulatory Guidelines

ICH Guidelines for Clinical Trials and Global Drug Development: A Complete Overview

May 2, 2025

digi

Formed in 1990, ICH unites regulatory authorities and industry representatives from the U.S., Europe, Japan, and beyond to develop harmonized technical guidelines for pharmaceuticals. Through its Quality, Safety, Efficacy, and Multidisciplinary guidelines, ICH ensures that products meet high standards across global markets while facilitating faster, safer, and more efficient drug development and approval processes.
Click to read the full article.

ICH Guidelines, Regulatory Guidelines

Challenges and Opportunities in ASEAN-Based Clinical Research

May 5, 2025

digi

One of the most significant obstacles in ASEAN clinical trials is the lack of regulatory harmonization. Although the ASEAN region is moving towards standardization through shared guidelines and the ASEAN Clinical Trials Network (ACTN), key challenges remain:
Click to read the full article.

ASEAN Guidelines, Regulatory Guidelines

Registration and Approval Timelines in ASEAN: Navigating Clinical Trial Start-Up

May 5, 2025

digi

In the ASEAN region, each country operates under its own regulatory authority responsible for clinical trial approvals. Some of the key agencies include:
Click to read the full article.

ASEAN Guidelines, Regulatory Guidelines

Differences in Informed Consent Documentation Across ASEAN Countries

May 5, 2025

digi

According to ICH-GCP and CDSCO standards, the following components are typically required in any informed consent form (ICF):
Click to read the full article.

ASEAN Guidelines, Regulatory Guidelines

Safety Monitoring Requirements in ASEAN Member States: A Clinical Trial Guide

May 5, 2025

digi

Safety monitoring refers to the systematic tracking, documentation, analysis, and reporting of adverse events that occur during a clinical trial. The goal is to detect risk signals early, protect participants, and ensure compliance with international Good Clinical Practice (GCP) standards such as EMA and USFDA guidelines.
Click to read the full article.

ASEAN Guidelines, Regulatory Guidelines

Import/Export Requirements for IP in ASEAN Trials: Navigating Regional Regulations

May 5, 2025

digi

Investigational Products are pharmaceutical forms of active ingredients or placebo being tested or used as a reference in a clinical trial. These include tablets, capsules, injectables, biologics, and vaccines. IPs must be handled with care, especially during cross-border transport, to ensure their identity, strength, quality, and purity remain intact.
Click to read the full article.

ASEAN Guidelines, Regulatory Guidelines

Ethics Committee Structures Across ASEAN Countries: Navigating Regional Variations

May 6, 2025

digi

An Ethics Committee is an independent body tasked with reviewing, approving, and monitoring biomedical research involving human subjects. Their goal is to ensure that all ethical and legal aspects of the study are in compliance with the GMP guidelines and the ASEAN GCP framework.
Click to read the full article.

ASEAN Guidelines, Regulatory Guidelines

Role of ACTR and the ASEAN Guidelines on GCP in Clinical Research

May 6, 2025

digi

Originally adapted from ICH E6, the ASEAN GCP Guidelines serve as the ethical and scientific foundation for conducting clinical trials within the ten ASEAN member states. While countries like Singapore and Malaysia have advanced GCP systems, the ASEAN-wide GCP guidelines aim to harmonize standards for:
Click to read the full article.

ASEAN Guidelines, Regulatory Guidelines

Harmonization of Clinical Trial Applications in ASEAN Countries

May 6, 2025

digi

The ASEAN bloc includes Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam—each with unique legal frameworks and health system capacities. The need for regulatory harmonization arises from:
Click to read the full article.

ASEAN Guidelines, Regulatory Guidelines