Regulatory Focus™ > News Articles > Regulatory Recon: China's New Drug Approval Backlog Soars (13 March 2015)

Regulatory Recon: China's New Drug Approval Backlog Soars (13 March 2015)

Posted 13 March 2015 | By Alexander Gaffney, RAC

Regulatory Recon: China's New Drug Approval Backlog Soars (13 March 2015)

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

In Focus: US

  • FDA Employees Were ‘Granting Approval Without Knowing Why,’ Judge Rules In Ranbaxy Case (Pink Sheet-$) (Opinion)
  • FDA Still Plans on Finalizing Generic Labelling Rule: Hamburg (FDAnews-$) (Pink Sheet-$)
  • Foundation takes issue with U.S. drug retailers on labelling, foreign manufacturing practices (Fierce)
  • S.F. Supervisors Vote To Expand Rx Drug Disposal Program; Pharmaceutical Firms Push Back (CA Healthline)
  • Johnson & Johnson sues Glaxo over allergy ads as spring nears (Reuters)
  • ‘Emotional’ NDACs Stymie OTC Switches – Former Chairman Wood (Tan Sheet-$)
  • Planning Board Urges FDA To Launch Postmarket Incubator Project (Silver Sheet-$)
  • Lawsuits Say Protein Powders Lack Protein, Ripping Off Athletes (Forbes)
  • Where's Hamburg headed after FDA? (SCRIP-$)

In Focus: International

  • China drug approval backlog jumped by a third last year (Reuters)
  • Guidelines on stem cell technology to be released in China (Want China Times)
  • PRAC recommends restrictions on the use of codeine for cough and cold in children (EMA)
  • PRAC recommends further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine (EMA)
  • MHRA: Good manufacturing practice: data integrity definitions and guidance (MHRA)
  • EU Notified Body Unannounced Audits and Your Suppliers (Emergo)
  • Clinical research: Regulatory uncertainty hits drug trials in India (PharmJournal)
  • 4 Reasons Why Your Firm Should Use A Single-Audit Program (Silver Sheet-$)

RAPS Wants Your Input

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US: Pharmaceuticals and Biotechnology

  • FDA Employees Were ‘Granting Approval Without Knowing Why,’ Judge Rules In Ranbaxy Case (Pink Sheet-$) (Opinion)
  • FDA Still Plans on Finalizing Generic Labelling Rule: Hamburg (FDAnews-$) (Pink Sheet-$)
  • Foundation takes issue with U.S. drug retailers on labelling, foreign manufacturing practices (Fierce)
  • S.F. Supervisors Vote To Expand Rx Drug Disposal Program; Pharmaceutical Firms Push Back (CA Healthline)
  • Johnson & Johnson sues Glaxo over allergy ads as spring nears (Reuters)
  • ‘Emotional’ NDACs Stymie OTC Switches – Former Chairman Wood (Tan Sheet-$)
  • What Does OPDP’s Enforcement Lull Mean? (CHC)
  • Recent FDA Antibiotic Approvals: Good News and Bad News (CDDEP)
  • FDA Formalizes Procedures for Expediting Review of Certain Applications with Breakthrough Therapy Designation (FDALawBlog)
  • FDA Asks for Help With Analyzing its Operations (FDA)
  • Background Analysis: US FDA Advisory Committee to Review The Medicine Company’s Cangrelor a Second Time – APR 15, 2015 (Tarius)
  • Actavis Receives FDA Approval of SAPHRIS for Pediatric Patients (age 10-17) for Acute Treatment of Manic or Mixed Episodes of Bipolar I Disorder (Press)
  • Brookings Webcast Today on the State of Biomedical Innovation (Brookings)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Pfizer's Lyrica Fails Phase 4 Study in Adolescents With Fibromyalgia (Press) (Reuters)
  • FDA to review re-submitted Bristol-Myers hepatitis C drug (Reuters) (Press) (SCRIP-$) (Pharmafile)
  • Baxter BioScience Announces Positive Phase III Results for BAX 817, Investigational Recombinant Treatment for Hemophila A and B Patients with Inhibitors (Press)
  • Neuralstem Stock Plunges After Latest Study on ALS Drug (The Street)

US: Pharmaceuticals and Biotechnology: General

  • Gilead and Vertex Shareholders Can Vote on Pricing Resolutions: SEC (Pharmalot)
  • Senators again target candy-coated drugs (The Hill)
  • Opioid Abuse Drops, Then Levels Off (MedPage Today)

US: Medical Devices

  • Planning Board Urges FDA To Launch Postmarket Incubator Project (Silver Sheet-$)
  • Toshiba’s Infinix 4D CT Receives FDA Clearance with Aquilion PRIME CT Configuration (Press)

US: Dietary Supplements

  • Lawsuits Say Protein Powders Lack Protein, Ripping Off Athletes (Forbes)
  • Companies selling cannabis-infused products warned by FDA on health claims (Reuters)
  • Excipients Exacerbate Confusion in NY Attorney General’s Flawed Supplement Testing (NPI)

US: Assorted And Government

  • Where's Hamburg headed after FDA? (SCRIP-$)
  • VA to start precision oncology research with Personal Genome Diagnostics (MedCityNews)
  • NIH researchers develop database on healthy immune system (Press)

Upcoming Meetings and Events

Europe

  • PRAC recommends restrictions on the use of codeine for cough and cold in children (EMA)
  • PRAC recommends further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine (EMA)
  • MHRA: Good manufacturing practice: data integrity definitions and guidance (MHRA)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March 2015 (EMA)
  • EU Notified Body Unannounced Audits and Your Suppliers (Emergo)
  • EFPIA Welcomes UK Move to Speed Patient Access to Innovative Drugs (EFPIA)
  • The EMA at 20: A quality model that deserves to be replicated (SCRIP-$)
  • The EMA at 20: The generic and biosimilar industries on taking a positive partnership forward (SCRIP-$)
  • What Happened When Class A Drugs Were Legalised In Ireland For Two Days (BuzzFeed)
  • NICE lifts Entyvio restrictions after Takeda offers discount (Pharmafile) (SCRIP-$) (PMLive)
  • Cancer Drugs Fund a ‘missed opportunity’, says MP (PMLive)
  • EC backs expanded approval of Novo Nordisk’s Tresiba for children (PharmaLetter-$)
  • UK’s NICE recommends Stelara for psoriatic arthritis (PharmaLetter-$)
  • Industry pays £310m to underwrite medicines bills (PMLive)

India

  • India’s Panacea Takes On Pfizer Over Prevnar 13 Patent Claims (PharmAsia-$)
  • Clinical research: Regulatory uncertainty hits drug trials in India (PharmJournal)
  • Centre urged to set up common technical advisory board and create independent medical device control officers (Pharmabiz)
  • India may set up new Ministry for pharmaceuticals sector (DNA India)

China

  • China drug approval backlog jumped by a third last year (Reuters)
  • China to regulate medical equipment for overseas market (Global Times)
  • Guidelines on stem cell technology to be released in China (Want China Times)

Canada

  • Health Canada Will Regulate Reprocessors Beginning In January (Silver Sheet-$)
  • Health Canada licensing of natural remedies 'a joke' (CBC)

Other International

  • 4 Reasons Why Your Firm Should Use A Single-Audit Program (Silver Sheet-$)
  • NSF International Announces Standards for Pharmaceutical Ingredients (PharmPro)

General Regulatory And Interesting Articles

  • Germany court orders measles sceptic to pay 100,000 euros (BBC)
  • Before I go: Time warps for a young surgeon with metastatic lung cancer (StanMed)
  • Robert Downey Jr. Delivers a Real Bionic Arm to Kid (YouTube)
  • Scientists Call For Moratorium On Human Genetic Experiments (BuzzFeed) (MIT TR)
  • Building Better Submissions (PharmaManufacturing)

Regulatory Reconnaissance #513 – 13 March 2015

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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