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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

New Research Compares Drug Regulators Around the Globe By Zachary Brennan - Published 11 August 2017

Pharmaceutical regulations vary widely in different countries, though new research published Friday in Nature Reviews Drug Discovery offers comparisons in terms of various regulators’ budgets, staff, new drug approvals and timelines for approvals.

Categories: News, Asia, Canada, Europe, US, Anvisa, CFDA, EMA, FDA, MHRA, PMDA, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: comparison of drug regulators, new drug approval times, drug regulator reviewers

Asia Regulatory Roundup: CFDA Seeks Feedback on Guidance for Medical Device Clinical Trial Sites (8 August 2017) By Nick Paul Taylor - Published 08 August 2017

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

Categories: News, Asia, CFDA, TGA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory strategy, Submission and registration

Tags: Asia Regulatory Roundup, China guidance

BIO Highlights IP Challenges Around the Globe By Zachary Brennan - Published 07 August 2017

As part of an effort to help the US Trade Representative understand and preserve strong intellectual property (IP) protections for US companies, the Biotechnology Innovation Organization (BIO) recently put together a report highlighting challenges worldwide and noting that IP reforms outside the US could improve conditions for exporting biotech products.

Categories: News, Africa, Asia, Middle East, Anvisa, CFDA, Biologics and biotechnology, Drugs, Government affairs

Tags: intellectual property BIO, biopharmaceutical patents, ANVISA, IP protections

Asia Regulatory Roundup: Pfizer, Sanofi Raise Concerns on TGA Complementary Medicine Proposal (18 July 2017) By Nick Paul Taylor - Published 18 July 2017

Pfizer and Sanofi have told the Therapeutic Goods Administration (TGA) its planned changes to the rules governing complementary medicines will increase regulatory burdens. The two big pharma companies were among the organizations to raise concerns proposed changes to TGA assessment pathways and other reforms will increase burdens while decreasing flexibility.

Categories: News, China, India, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, Regulatory Roundup

Asia Regulatory Roundup: CFDA Expands Trial Data Quality Monitoring Drive to Cover Medical Devices (11 July 2017) By Nick Paul Taylor - Published 11 July 2017

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

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

Tags: Asia Regulatory Roundup, J&J, Boehringer Ingelheim

Asia Regulatory Roundup: Australia Opens Priority Review Pathway (27 June 2017) By Nick Paul Taylor - Published 27 June 2017

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

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

Tags: priority review, China in ICH, CFDA backlog, Indian pharmaceuticals

Asia Regulatory Roundup: India Sets Guidelines for Fixed-Dose Combination Trials (13 June 2017) By Nick Paul Taylor - Published 13 June 2017

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

Categories: News, Asia, CDSCO, CFDA, Crisis management, Drugs, Government affairs

Tags: Asia Regulatory Roundup, India clinical trials, CFDA guidance

Asia Regulatory Roundup: CFDA Ordered More Inspections of Foreign Manufacturers in 2016, But Visited Fewer Sites (6 June 2017) By Nick Paul Taylor - Published 06 June 2017

The China Food and Drug Administration (CFDA) has released a breakdown of the good manufacturing practice (GMP) inspections it performed last year. The report shows another year of growth in the number of inspections of overseas manufacturers ordered by CFDA, yet the agency only performed a fraction of these planned visits.

Categories: News, China, India, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance

Tags: Regulatory Roundup, Asia Regulatory Roundup

Asia Regulatory Roundup: India’s NPPA Withdraws List of Pricing Rule Violators (30 May 2017) By Nick Paul Taylor - Published 30 May 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, In vitro diagnostics, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, NPPA, Roche, Kazakhstan

Asia Regulatory Roundup: CFDA Seeks to Exempt More Devices From Clinical Trials (23 May 2017) By Nick Paul Taylor - Published 23 May 2017

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

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

Tags: Asia Regulatory Roundup, NPPA, medical device exemptions, PIC/S

Asia Regulatory Roundup: CFDA Offers New Drug, Device Draft Guidance (16 May 2017) By Nick Paul Taylor - Published 16 May 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, Regulatory intelligence, Regulatory strategy

Tags: CFDA guidance, medical device prices in India, Australia drug ads

Regulatory Recon: French Regulators Halt ALS Trial; FDA Revisits Opioid Prescriber Training (12 May 2017) By Zachary Brennan - Published 12 May 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Canada, Europe, US, CFDA, EMA, FDA, MHRA, NICE, WHO, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Asia Regulatory Roundup: Indian Watchdog Probes Allegations Roche Tried to Influence Regulators (2 May 2017) By Nick Paul Taylor - Published 02 May 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, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Medtronic, Abbott, Roche, Herceptin, biosimilars

Asia Regulatory Roundup: India Looks to Reform Drug Pricing Legislation (18 April 2017) By Nick Paul Taylor - Published 18 April 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, In vitro diagnostics, Medical Devices, Regulatory strategy

Tags: Asia regulatory roundup, India drug pricing, CFDA clinical trial, China drug regulations

Asia Regulatory Roundup: CFDA Increases Drug Regulation Budget by 31% (11 April 2017) By Nick Paul Taylor - Published 11 April 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, Regulatory intelligence, Regulatory strategy

Tags: data integrity, DCGI, pharma manufacturing, DRAP, stents

Regulatory Recon: US FDA Approves Drugs Faster Than EMA (6 April 2017) By Zachary Brennan - Published 06 April 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Asia, Europe, US, CFDA, EC, EMA, FDA, TGA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Global Regulatory Developments in Cell and Gene Therapy, Drug Manufacturing Inspections, Regulatory Intelligence Tools and a Preview of March By Gloria Hall - Published 08 March 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in March.

Categories: Features, CFDA, EMA, FDA, Health Canada, ISO, Biologics and biotechnology, Human cell and tissue, Regulatory intelligence, Regulatory strategy

Tags: Regulatory Focus, Feature Articles, Feature Summary

Asia Regulatory Roundup: TGA Increases Inspections Following Adoption of Risk-Based Approach (7 March 2017) By Nick Paul Taylor - Published 07 March 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, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, TGA inspections, NPPA

International Generic Drug Regulators Unveil New Biowaiver Assessment Template By Zachary Brennan - Published 01 March 2017

Regulatory authorities participating in the International Generic Drug Regulators Programme (IGDRP) have crafted and released a Biopharmaceutics Classification System (BCS) Biowaiver Assessment Report template for use by its members.

Categories: News, Asia, Canada, Europe, US, CFDA, EMA, FDA, Health Canada, WHO, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: IGDRP, biowaivers, Biopharmaceutics Classification System

Asia Regulatory Roundup: J&J, Novartis and Pfizer Comment on Australian Risk Management Proposals (28 February 2017) By Nick Paul Taylor - Published 28 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, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, Pfizer, J&J, Novartis, stents

China Works to Reduce Massive Backlog of Clinical Trial and Marketing Applications By Zachary Brennan - Published 15 February 2017

China Food and Drug Administration (CFDA) is facing increasing pressure as a backlog of pharmaceutical marketing and clinical trial applications grow, though trial standards there are approaching those of international standards, according to a perspective published in Nature Reviews Clinical Oncology on Tuesday.

Categories: News, China, CFDA, Biologics and biotechnology, Clinical, Compliance, Drugs, Government affairs

Tags: CFDA, clinical trials in China, drug approvals in China

CFDI's Global Drug Inspection Trend Study Offers Regulatory Updates and Opinions By Yingying Liu, Siegfried Schmitt - Published 15 February 2017

To help keep regulatory professionals up-to-date on current thinking by global regulatory agencies, the Chinese Center of Food and Drug Inspection (CFDI) released a new electronic journal covering hot topics and developments in international drug manufacturing inspections. This article summarizes the key points including regulatory thinking and opinions from global regulatory authorities and organizations; timely updates on regulations, guidance, regulatory measures and changes; and inspection case analysis through observations by various international regulatory authorities.

Categories: Features, China, CFDA, FDA, WHO, Government affairs, Regulatory intelligence

Tags: Chinese Center of Food and Drug Inspection, CFDI

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

Asia Regulatory Roundup: India Adopts New Medical Device Regulations (7 February 2017) By Nick Paul Taylor - Published 07 February 2017

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

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

Tags: India medical device regulations, DRAP, TFDA