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: generic drug

US-FDA Publishes New Requirements for OTC Drugs Labeling

On September 8,2022, FDA published the draft of a guideline that provides recommendations on the labeling of OTC drugs.

FDA publishes product-specific guidances to facilitate generic drug development

FDA publishes product-specific guidance’s to facilitate generic drug development.

Overview of generic drug registration with USFDA

Drug companies must submit an abbreviated new drug application (ANDA) to FDA for approval to market a generic drug.

THE US-FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain

FDA published FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain.

THE US-FDA publishes product-specific guidances (PSGs) to facilitate generic drug development

On May 2022, the FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval, helping to streamline generic product

The US FDA Announces OTC Monograph Drug User Fee Rates for FY2021

On December 28, 2020 , the U.S. Food and Drug Administration ( FDA) announced the rates for over the counter (OTC) monograph drug user fees for fiscal year (FY) 2021.

China’s NMPA resolves issues regarding current administration on drug distribution

NMPA announces a new revised Drug Administration Law of the People’s Republic of China effective since Dec 1, 2019.

Mexico’s COFEPRIS establishes new electronic Appointment System

From September,1st 2020 COFEPRIS establishes the request for appointments will be via the internet and face-to-face attention in the CIS for the entry of priority formalities.

Mexico’s COFEPRIS promotes the production of generic drugs with new operating rules

COFEPRIS establishes operating rules to promote the production of generic drugs in Mexico, by eliminating criteria that limited their production and their availability at more accessible prices for the population.

The FDA publishes FY 2019 GDUFA Science and Research Report

THE FDA PUBLISHES FY 2019 GDUFA SCIENCE AND RESEARCH REPORT

The FDA’s FY 2019 GDUFA report provides detailed results for 13 areas of focus, including research activities and comprehensive lists of grants and contracts.

Anvisa’s Call Notice 2/2020 : Similar Drug Notice

Call Anvisa Call Notice 02-2020 Similar Drugs- Specific Subject Code

On Thursday (1/30), Anvisa published Call Notice 2/2020 , aimed at requesting information on similar drugs registered in Brazil.

Accelerated Approval of Detection Reagents of Coronavirus in China

person getting blood taken

The Emergency Approval of Novel Coronavirus Nucleic Acid Detection Reagent has shown the NMPA accelerated approval of seven NAD Reagents in only four days before going to the market.

← 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!