Search Results for GMP

Showing 1 – 25  of 77

EMA and FDA to Begin Sharing Commercially Confidential Information By Zachary Brennan - Published 23 August 2017

As part of a landmark agreement forged in March, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) said Wednesday that they will now share non-public and commercially confidential information, including trade secret information.

Categories: News, Europe, US, EC, EMA, FDA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Regulatory strategy

Tags: EMA and FDA agreement, mutual recognition agreement, GMP inspection reports

ICH Details Pilot Training Programs for 2017 By Michael Mezher - Published 16 August 2017

The International Council for Harmonization (ICH) has released details for five upcoming training programs in the US, Germany and Japan.

Categories: News, Japan, Europe, US, ICH, Clinical, Drugs, Manufacturing, Submission and registration

Tags: ICH, Training, eCTD, GMP, GCP

Asia Regulatory Roundup: No Manufacturers Have Complied With India's GMP Request (15 August 2017) By Nick Paul Taylor - Published 15 August 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, DCGI, GMP/GLP

FDA Warns Chinese Manufacturer for GMP, Training Issues By Michael Mezher - Published 15 August 2017

The US Food and Drug Administration (FDA) has warned Chinese manufacturer Foshan Flying Medical Products for testing and validation issues at its Guangdong, China facility.

Categories: News, China, US, FDA, Compliance, Over the counter drugs

Tags: Warning Letter, GMP

Quality Certificates for Small Molecule Drug Product Applications for International Regulatory Submissions By Monika Jain, PhD - Published 02 June 2017

This article provides a global overview of the general requirements and issues regulatory professionals may encounter while arranging for a variety of certificates for applications for small molecule drug products to be marketed internationally in the EU, US, Canada, Australia and Japan.

Categories: Features, Japan, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, PMDA, TGA, Drugs, Submission and registration

Tags: Quality Certificates, eCTD, GMP

European Regulatory Roundup: EMA Issues Increasing Number of GMP Non-Compliance Statements in India (11 May 2017) By Nick Paul Taylor - Published 11 May 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: European regulatory roundup, PRAC, GMP inspections, flu vaccine guidance

Asia Regulatory Roundup: Australia Scraps Target Date for Processing GMP Applications (25 April 2017) By Nick Paul Taylor - Published 25 April 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, MFDS, TGA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia regulatory roundup, GMP applications, stents, antimicrobial resistance

MHRA Investigates GMP Deficiency Trends From 2016 By Zachary Brennan - Published 18 April 2017

The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Tuesday released a new report on the trends seen from inspecting pharmaceutical manufacturing plants and evaluating their good manufacturing practices (GMPs).

Categories: News, Europe, MHRA, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: GMP deficiencies, pharmaceutical inspections, GMP deficiency trends

Pharmaceutical Inspection Co-operation Scheme Offers New Strategic Plan Through 2019 By Zachary Brennan - Published 08 March 2017

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week unveiled a new road map for the next two years during its February meeting in Switzerland, which was attended by representatives of 37 of its regulatory authorities.

Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, MHRA, Drugs, Government affairs, Manufacturing

Tags: PIC/S, GMP guidelines, regulatory affairs

US and EU Forge Landmark Agreement to Mutually Recognize Drug Manufacturing Inspections By Zachary Brennan - Published 02 March 2017

After wrangling over the details of trade secrets and inspection differences, the US and EU on Thursday finally announced they have agreed to mutually recognize one another’s pharmaceutical manufacturing inspections – a deal likely to lead to less duplicative inspections and lower costs on both sides of the Atlantic.

Categories: News, Europe, US, EC, EMA, FDA, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: GMP inspections, EMA and FDA initiatives, mutual recognition agreements, US-EU international agreement

Updated: TTIP on Thin Ice Not Likely to Delay US-EU Mutual GMP Recognition Deal By Zachary Brennan - Published 22 February 2017

A deal to further harmonize and mutually recognize good manufacturing practice (GMP) inspections between the US and EU will not be delayed, as the EU ambassador to the US said Wednesday that the Transatlantic Trade and Investment Partnership (TTIP) is in a state of pause as there is no one within President Donald Trump’s administration with whom to continue discussions.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: mutual GMP recognition, TTIP, EU-US trade deals

Asia Regulatory Roundup: India Asks China to Expedite GMP Inspection to Resolve a Drug Shortage (14 February 2016) By Nick Paul Taylor - Published 14 February 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing

Tags: Asia Regulatory Roundup, drug shortage, GMP inspection, India online portal

European Regulatory Roundup: UK Fines Pfizer for 2,600% Price Hike (8 December 2016) By Nick Paul Taylor - Published 08 December 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: European Regulatory Roundup, Pfizer, ATMP, GMP manufacturing, antimicrobial resistance

Asia Regulatory Roundup: CFDA Shifts to Random Inspections (6 December 2016) By Nick Paul Taylor - Published 06 December 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, ANZTPA, CDSCO, CFDA, Medsafe, TGA, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: GMP pharmaceutical manufacturing, Chinese drug inspections, DTAB, Sugam, Asia Regulatory Roundup

FDA Warns Spanish API Maker for GMP Violations By Michael Mezher - Published 06 December 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Spanish active pharmaceutical ingredient (API) maker Interquim, S.A. for several good manufacturing practices (GMP) violations uncovered during an inspection of the company's Barcelona facility last May.

Categories: News, Europe, US, FDA, Active pharmaceutical ingredients, APIs, Manufacturing

Tags: Warning Letter, Good Manufacturing Practice, GMP

US, EU Look to Mutually Recognize GMP Inspections by January 2017 By Zachary Brennan - Published 26 October 2016

The US and EU say they have made more progress on harmonizing good manufacturing practice (GMP) inspections and could reach a deal by January 2017, according to a report on the 15th round of negotiations for the Transatlantic Trade and Investment Partnership (TTIP).

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: GMP inspections, regulatory harmonization, UDIs, quality inspections

FDA Warns Four Foreign Drug Manufacturers By Zachary Brennan - Published 11 October 2016

The US Food and Drug Administration (FDA) on Tuesday released four warning letters sent in September to drug manufacturers from China, the UK, the Netherlands and Switzerland.

Categories: News, Asia, Europe, US, FDA, Compliance, Crisis management, Government affairs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: FDA warning letter, GMP violations, drug manufacturing problems

EU, Japan to Share More Information on GMP Inspections By Zachary Brennan - Published 05 October 2016

The European Directorate for the Quality of Medicines and Healthcare (EDQM) this week announced a new agreement with Japanese authorities to share more information on the outcome of good manufacturing practice (GMP) inspections of manufacturing sites of active pharmaceutical ingredients (APIs) of interest to both Europe and Japan.

Categories: News, Japan, Europe, EMA, MHLW, PMDA, Government affairs, Manufacturing

Tags: mutual recognition of GMP inspections, EMA and PMDA, Pharmacopoeia

Asia Regulatory Roundup: India’s DCGI Orders Manufacturers to Assess GMP, GLP Compliance (30 August 2016) By Nick Paul Taylor - Published 30 August 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Clinical, Crisis management, Drugs, Government affairs, Human cell and tissue

Tags: TGA, DCGI, GLP, GMP, stem cells

EU Bans Non-Critical, Sterile Products from a Pfizer Site in India Following Joint Inspection By Zachary Brennan - Published 19 August 2016

A statement of noncompliance released by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday effectively bans in the EU medicinal products considered non-critical to public health from Pfizer's Irungattukottai, India-based site following an inspection with four regulators.

Categories: News, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, MHRA, TGA, Active pharmaceutical ingredients, Drugs, Manufacturing, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: GMP inspection, Pfizer, India drug manufacturing, antibiotics manufacturing

Data Integrity: New Draft Guidance and Q&A By Zachary Brennan - Published 11 August 2016

The European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on Thursday released new draft guidance and a question and answer document to help ensure that data integrity is maintained during the process of testing, manufacturing, packaging, distributing and monitoring medicines.

Categories: News, Africa, Asia, Canada, Europe, Middle East, Oceania, US, EMA, FDA, Active pharmaceutical ingredients, Business Skills, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: PIC/S, data integrity of medicines during manufacturing, pharmaceutical manufacturing, GMP drug manufacturing

FDA, Health Canada Look to Implement Common Electronic Submission System By Zachary Brennan - Published 09 August 2016

As part of efforts to further align the US Food and Drug Administration (FDA) and Health Canada, both sides are working to implement a common electronic submission gateway to allow pharmaceutical companies to submit large electronic documents simultaneously to both regulators.

Categories: News, Canada, US, FDA, Health Canada, Drugs, Ethics, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: mutual recognition of GMP assessments, pharmaceutical regulatory sharing, drug regulators

Indian Sites From Pfizer, Wockhardt Face Complications After GMP Inspections By Zachary Brennan - Published 08 August 2016

Pfizer and Wockhardt are struggling to keep pace with pharmaceutical good manufacturing practice (GMP) regulations as two recent inspections of their manufacturing sites in India resulted in a US ban for Wockhardt and a temporary suspension of the Pfizer site.

Tags: Pfizer, Wockhardt, India drug manufacturing, GMP inspections

FDA Continues Crackdown on Chinese Drug Manufacturers With new Warning for Xiamen By Michael Mezher - Published 02 August 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter to Chinese drug manufacturer Xiamen Origin Biotech over "significant deviations" in the company's manufacturing practices for active pharmaceutical ingredients (APIs).

Categories: News, China, US, FDA, Active pharmaceutical ingredients, Drugs, Manufacturing

Tags: Xiamen Origin Biotech, Warning Letter, GMP, Import Alert

Updated: FDA and EMA Progressing Toward Mutual Recognition of GMP Inspections By Zachary Brennan - Published 29 June 2016

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) are making significant progress toward mutually recognizing each other’s good manufacturing practice (GMP) pharmaceutical inspections.

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, US, Anvisa, EMA, FDA, ICH, MHRA, TGA, WHO, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: ICMRA, GMP inspections, mutual recognition, FDA and EMA relationship