Skip to content
  • About GRP
    • Why Choose Us
    • Leadership
    • Brochure
    • Careers
  • Countries
    • Canada’s Health Canada
    • United States’ FDA
    • Brazil
    • Mexico’s COFEPRIS
    • Europe’s EMA
    • Australia
    • China
    • Japan’s PMDA
    • Korea’s Ministry of Food and Drug Safety (MFDS)
    • Taiwan’s Food and Drug Administration (TFDA)
    • Singapore’s HSA
    • India’s CDSCO

    North America

    Canada

    United States of America

    Latin AMerica

    Brazil

    Mexico

    Europe

    European Union

    Australia

    Australia

    Asia

    China

    Japan

    South Korea

    Taiwan

    Singapore

    India

  • Services

    Medical Devices

    • Authorized Local Agent
    • Regulatory Intelligence
    • Regulatory Strategy
    • Regulatory Affairs
    • Product Registration
    • Medical Writing
    • Health Authority Consultation
    • Clinical

    Pharmaceuticals

    • Authorized Local Agent
    • Regulatory Intelligence
    • Regulatory Strategy
    • Regulatory Affairs
    • Product Registration
    • Regulatory Operations
    • Health Authority Consultation

    Nutraceuticals / Food Supplements

    • Authorized Local Agent
    • Regulatory Intelligence
    • Regulatory Affairs
    • Regulatory Strategy
    • Verification of Nutrient Claims
    • Verification of Health Claims

    Cosmetics & Personal Care Products

    • Authorized Local Agent
    • Regulatory Intelligence
    • Regulatory Affairs
    • Regulatory Strategy
    • Cosmetic Packaging and Labeling Review
    • Product Classification and Formulation Review

    Pharmacovigilance

    • Overview
    • GRP Pharmacoviglance Services

    Quality

    • Preparation for FDA Inspections
    • GMP Mockup Quality Audits
    • ISO 13485 Quality Audits
    • GCP Audits
    • cGTP Audits
    • GAP Analysis Audits
    • Foreign Manufacture Accreditation (FMA)
    • QA SOPs Development
  • Resource Center
    • Blog
    • Market Access Special Programs
    • Press Releases
    • White Papers
    • Case Studies
    • Videos
    • Presentations
    • Brochure
  • RI Platform
    • Japan Regulatory Intelligence (RI)
    • China (NMPA) Regulatory Intelligence
    • Brazil
    • Mexico Regulatory Intelligence (RI)
    • USA Regulatory Intelligence (RI)

    Japan

    • Health Authority
    • Medical Device
    • Pharmaceuticals
    • Clinical Trials
    • Cosmetics
    • Food Supplements

    China

    • Health Authority
    • Medical Device
    • Pharmaceuticals
    • Clinical Trials
    • Cosmetics
    • Food Supplements

    Brazil

    • Health Authority
    • Medical Device
    • Pharmaceuticals
    • Clinical Trials
    • Cosmetics
    • Food Supplements

    Mexico

    • Health Authority
    • Medical Device
    • Pharmaceuticals
    • Clinical Trials
    • Cosmetics
    • Food Supplements

    USA

    • Medical Device
    • Pharmaceuticals
    • Clinical Trials
    • Cosmetics
    • Food Supplements
  • Contact Us
  • About GRP
    • Why Choose Us
    • Leadership
    • Brochure
    • Careers
  • Countries
    • Canada’s Health Canada
    • United States’ FDA
    • Brazil
    • Mexico’s COFEPRIS
    • Europe’s EMA
    • Australia
    • China
    • Japan’s PMDA
    • Korea’s Ministry of Food and Drug Safety (MFDS)
    • Taiwan’s Food and Drug Administration (TFDA)
    • Singapore’s HSA
    • India’s CDSCO
  • Services
  • Resource Center
    • Blog
    • Market Access Special Programs
    • Press Releases
    • White Papers
    • Case Studies
    • Videos
    • Presentations
    • Brochure
  • RI Platform
    • Japan Regulatory Intelligence (RI)
    • China (NMPA) Regulatory Intelligence
    • Brazil
    • Mexico Regulatory Intelligence (RI)
    • USA Regulatory Intelligence (RI)
  • Contact Us
Menu
  • About GRP
    • Why Choose Us
    • Leadership
    • Brochure
    • Careers
  • Countries
    • Canada’s Health Canada
    • United States’ FDA
    • Brazil
    • Mexico’s COFEPRIS
    • Europe’s EMA
    • Australia
    • China
    • Japan’s PMDA
    • Korea’s Ministry of Food and Drug Safety (MFDS)
    • Taiwan’s Food and Drug Administration (TFDA)
    • Singapore’s HSA
    • India’s CDSCO
  • Services
  • Resource Center
    • Blog
    • Market Access Special Programs
    • Press Releases
    • White Papers
    • Case Studies
    • Videos
    • Presentations
    • Brochure
  • RI Platform
    • Japan Regulatory Intelligence (RI)
    • China (NMPA) Regulatory Intelligence
    • Brazil
    • Mexico Regulatory Intelligence (RI)
    • USA Regulatory Intelligence (RI)
  • Contact Us

Category: Preventative Measures

Brazil’s Anvisa defines requirements for requests for emergency use of vaccines

A guide prepared by Anvisa provides guidance to development companies on procedures for emergency use authorization of Covid-19 vaccines.

Brazil’s Anvisa is approved for Pharmaceutical Inspection Co-operation Scheme – PIC/S

Brazil’s ANVISA has completed the process of joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The Agency will become the 54th member of the international pharmaceutical inspection initiative.

Registration Of COVID-19 Rapid Tests with Brazil’s Anvisa- Required Documents

Anvisa published the Resolution (RDC 348/2020) to speed up the evaluation of new products for detection of the new coronavirus (SARSCoV-2). Check out GRP’s blog on all the required documents necessary to register COVID-19 rapid tests with Brazil’s Anvisa.

Australia’s TGA GMP inspections during COVID-19

During the duration of the COVID-19 pandemic, the TGA will only use remote and hybrid inspections to minimize potential impacts of on-site inspection of GMP clearance.

United Kingdom’s MHRA releases a list of exempted medical devices

United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) developed a list of medical devices which can be marketed without CE marking.

Steps to take if you have a COVID-19 confirmed positive worker: CDC Recommendations

The FDA encourages and outlines major steps to be taken as per the CDC recommendations to help prevent and slow the COVID-19 in the office.

China’s NMPA issues Guideline for changes of Raw Material in Passive Medical Device Products.( No. 33 2020)

China’s NMPA issued a guidance (No 33. 2020) on May 19, 2020 to provide a guideline and systematic approach for risk analysis of raw material changes in passive medical device products .

Brazil’s Anvisa Registration Requirements for COVID-19 Rapid Test

On May 14, 2020 Brazil’s Anvisa published information on the requirements of the registration of the rapid tests for COVID-19 in Brazil.

Opening Up America Again: The Phased Approach & OSHA recommendations on Work Safety

The United States White House and Center of Disease Control (CDC) have released on May 14 the phased approach on “Opening Up America Again.”

The Office of Human Research Protection Issues Guidance on the Conduct of Clinical trials During COVID-19

On April 8, 2020 the USA’s Office of Human Research Protections (OHRP) released a guidance on  Human Subject Protection Regulations included under regulation 45 CRF part 46, which applies to COVID-19 response. 

How to make a Home-Made Face Mask: Health Authorities Recommendations

Learn how to make a home-made face mask based on health authority recommendations around the world.

FDA Emergency Use Authorization (EUA) for Face Masks Intended for a Medical Purpose, Surgical Face Masks and N95 Respirators

To increase the availability of Face Masks Intended for the protection of health care professionals the FDA will expedite the review of unapproved devices under the Emergency Use Authorization (EUA) process.

← older

COMPANY

  • About US
  • Leadership
  • Why Choose Us

useful links

  • Contact Us
  • Brochures
  • Resource Center

GRP Headquarters

550 Cochituate Road
Framingham,  01701, MA, USA
Tel : (+1 ) 781 - 672 -4200
Twitter Youtube Linkedin
  • Privacy Policy
  • Terms & Conditions
  • Cookies Policy
  • Other Policies

Copyright ©2023 Global Regulatory Partners

Contact Us!