Author: admin

Building Regulatory Capacity: Best Practices for the Future

March 26, 2020
Standards

Pharmaceutical companies are using various methodologies to ensure regulatory compliance with the health authorities. Still, there remains a loophole that prevents them from crossing the barriers set...

European Medicines Agency – Explanatory Note on Implementation of ICH Q12 Guideline

March 17, 2020
Standards

European Medicines Agency (EMA) explained considerations for implementing the International Council of Harmonisation’s (ICH) Q12 guideline on technical and regulatory considerations for pharmaceutical...

Danish Medicines Agency: Newly Improved Reporting Requirement to Strengthen the Surveillance of Medical Devices

March 17, 2020
Medical Device

The Danish Medicines Agency recommended newly enhanced reporting requirements on medical devices to ensure that the surveillance of medical devices becomes more focused for the benefit of patients. This...

Drug Regulatory Authority of Pakistan (DRAP) Establishing Regulatory Pathway for Licensing System: A Progressive Approach

March 17, 2020
Biopharma

Drug Regulatory Authority of Pakistan (DRAP) implementing revised Licensing System, to ensure that all establishments comply with the Risk Based current Good Manufacturing Practices(GMPs) requirements...

USA: CDRH drafts Guidance on Contact Lenses – Performance Criteria to Support 510(k)s

March 17, 2020
Medical Device

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released new draft guidance to support firms planning to submit a 510(k) using the Safety and Performance...

FDA Drafts Guidance for Regulatory Submissions in Alternate Electronic Format

March 17, 2020
Standards

The US Food and Drug Administration (FDA) issued draft guidance providing recommendations on an alternate electronic format for submissions that qualify for an exemption or waiver from electronic common...