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Filtering on: "geography asia"

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Asia Regulatory Roundup: India to Reassess Cardiac Stent Price Ceiling (19 September 2017) By Nick Paul Taylor - Published 19 September 2017

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

Categories: News, Asia, CFDA, TGA, Drugs, Medical Devices

Tags: Asia Regulatory Roundup

FDA Warns Korean, Chinese Drugmakers By Zachary Brennan - Published 19 September 2017

The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent recently to Korea-based Firson Co. and China's Wuxi Medical Instrument Factory detailing the firms' violations.

Categories: News, Asia, US, FDA, Drugs, Manufacturing

Tags: FDA warning letters, Wuxi Medical, Firson

Malaysia Issues Compulsory License for Gilead Hepatitis C Drug By Zachary Brennan - Published 15 September 2017

Late last month, Malaysia’s government issued a compulsory license in an effort to offer a less-expensive version of Gilead’s hepatitis C drug and increase access.

Categories: News, Asia, Drugs

Tags: Malaysia, Gilead, Hepatitis C, compulsory license

Regulatory Recon: Phase III Cancer Vaccine Trial Fails; EMA’s CHMP Recommends 13 Medicines for Approval (15 September 2017) By Zachary Brennan - Published 15 September 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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

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

Asia Regulatory Roundup: TGA Takes Tougher Line on Incomplete GMP Clearance Applications (12 September 2017) By Nick Paul Taylor - Published 12 September 2017

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

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

Tags: Asia Regulatory Roundup

MDSAP Update: Canada's 2019 Deadline Still on Track By Michael Mezher - Published 11 September 2017

Speaking at RAPS' 2017 Convergence on Monday, officials from two international regulators and representatives from auditing organizations offered the latest on the Medical Device Single Audit Program (MDSAP).

Categories: News, Japan, Canada, Latin America and Caribbean, Oceania, US, Anvisa, FDA, Health Canada, MHLW, PMDA, TGA, Medical Devices

Tags: MDSAP, Medical Device Single Audit Program

Updated: FDA Form 483 for Celltrion May Offer a Glimpse Into Limited Uptake for Remicade Biosimilar By Zachary Brennan - Published 06 September 2017

The US Food and Drug Administration (FDA) on Wednesday released a Form 483 sent to Korea’s Celltrion with 12 observations, which an industry analyst believes could be the reason why the commercialization of Celltrion and Pfizer’s Inflectra (infliximab-dyyb), a biosimilar to Remicade, has not gone as well as planned in the US.

Categories: News, Asia, US, FDA, Biologics and biotechnology, Crisis management

Tags: Celltrion, Form 483, Pfizer, Inflectra

CDRH Releases 8 Warning Letters for Foreign, US Device Manufacturers By Zachary Brennan - Published 06 September 2017

About a week after the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) was criticized for sending a historically low number of warning letters so far in 2017, a flood of new letters were released Wednesday.

Categories: News, Asia, Europe, US, CDRH, Manufacturing, Medical Devices

Tags: warning letters, medical device warnings

Asia Regulatory Roundup: Drugmakers Push Back on Data Requirements in Australia’s Provisional Approval Pathway (5 September 2017) By Nick Paul Taylor - Published 05 September 2017

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

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

Tags: Asia Regulatory Roundup, Pfizer, inspections

IPRF and IGDRP to Consolidate Regulatory Initiatives in 2018 By Zachary Brennan - Published 31 August 2017

The International Pharmaceutical Regulators Forum (IPRF) and International Generic Drug Regulators Programme (IGDRP) have agreed to consolidate their work into a joint initiative that is expected to be operational in January 2018.

Categories: News, Asia, Canada, Europe, US, EC, EMA, FDA, Health Canada, ICH, MHRA, WHO, Drugs, Regulatory intelligence, Regulatory strategy

Tags: IPRF, IGDRP, pharmaceutical regulations

FDA Warns Indian Contract Manufacturer Hetero Labs By Zachary Brennan - Published 29 August 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to India-based contract manufacturer Hetero Labs’ manufacturing site on the outskirts of Hyderabad for significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

Categories: News, India, FDA, Drugs, Due Diligence, Manufacturing

Tags: Hetero Labs, FDA warning letters

Asia Regulatory Roundup: Roche Cancer Drug First to Win TGA Priority Review Status (29 August 2017) By Nick Paul Taylor - Published 29 August 2017

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

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

Tags: Asia Regulatory Roundup, Roche, DCGI

FDA Warns Chinese OTC Drugmaker for GMP, Data Integrity Issues By Michael Mezher - Published 24 August 2017

The US Food and Drug Administration (FDA) has warned Chinese over-the-counter (OTC) drug and cosmetics maker Bicooya Cosmetics Limited over poor sanitary conditions and data integrity issues at its Zhejiang, China facility.

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

Tags: Warning Letter, Inspection, Data Integrity

Pfizer Wins Indian Patent on Prevnar 13 Vaccine By Zachary Brennan - Published 22 August 2017

India’s patent office has granted Pfizer a patent on its pneumococcal conjugate vaccine (PCV), known as Prevnar 13, after Doctors Without Borders (MSF) challenged the patent’s claims.

Categories: News, Asia, Europe, US, Crisis management, Drugs, Regulatory strategy

Tags: Prevnar 13, Pfizer, PCV, pneumonia vaccine

Regulatory Recon: J&J Pays $417M for Baby Powder Link to Cancer (22 August 2017) By Zachary Brennan - Published 22 August 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, MHRA, PMDA, WHO, Drugs, Government affairs, Medical Devices

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

Asia Regulatory Roundup: China’s Supreme Court Clarifies Legal Scope to Punish Trial Data Fraudsters (22 August 2017) By Nick Paul Taylor - Published 22 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, Government affairs, Medical Devices

Tags: NPPA, knee implants, pharmacovigilance

Regulatory Recon: Novo Diabetes Drug Succeeds in Key Trial; Generic Drugmakers Feel Pinch as Prices Crumble (17 August 2017) By Zachary Brennan - Published 17 August 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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

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

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

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

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

German Regulators Slam Dr. Reddy's Plant for Critical, Major Deficiencies By Zachary Brennan - Published 10 August 2017

Regulators working for the Central Authority for Supervision of Medicinal Products in Bavaria have published a statement of non-compliance with good manufacturing practices (GMP) following an August inspection of a Hyderabad, India-based manufacturing site run by Dr. Reddy's Laboratories.

Categories: News, Asia, Europe, EC, FDA, Drugs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: Dr. Reddy's, competent authorities, EudraGMDP

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

WHO Drafts New Prequalification Timeline, KPIs By Zachary Brennan - Published 07 August 2017

As part of efforts to better monitor and improve the performance of its prequalification program, the World Health Organization (WHO) has proposed a new algorithm to calculate the prequalification timeline and drafted new key performance indicators (KPIs) to track. 

Categories: News, Asia, Europe, US, WHO, Biologics and biotechnology, Drugs, In vitro diagnostics, Regulatory intelligence, Regulatory strategy

Tags: WHO prequalification

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