Regulatory Focus™ > News Articles > Regulatory Recon: China to Remove Drug Price Controls (5 May 2015)

Regulatory Recon: China to Remove Drug Price Controls (5 May 2015)

Posted 05 May 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: China to Remove Drug Price Controls (5 May 2015)

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

In Focus: US

  • ANDA Approval Whiplash: Strong April Follows Terrible March (Pink Sheet-$)
  • Generic Drug Manufacturers Have Less than 1 Month to Self-Identify to FDA (Registrar Corp)
  • Should Congress Set up a "Free to Choose" Approval Track for New Drugs? (Fox)
  • Cancer drug spend tops $100bn in 2014 (PMLive) (Fierce) (Reuters) (SCRIP-$)
  • Appeals court rejects case claiming Medtronic's Infuse device harmed patient (StarTribune)
  • FDA Device Center Names New Deputy Policy Director (Gray Sheet-$)
  • Researchers question safety of off-label device use in atrial fibrillation, call for 510(k) review process (Fierce) (MPT) (HealthDay)

In Focus: International

  • China to remove drug pricing controls next month (PharmaTimes) (Reuters) (Fierce)
  • China proposes new rules on safely handling vaccines; detailed company records a must (Fierce)
  • Canada: Better documentation of adverse drug reactions needed to improve drug safety (MNT) (CBC)
  • Japan to adopt CDISC clinical data standards from October 2016 (Fierce)
  • API firms stand to gain by seeking prequalification says the WHO (OutsourcingPharma)
  • Market access for specialist medicines in the UK: the Price is Right? (PharmaPhorum)

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US: Pharmaceuticals and Biotechnology

  • ANDA Approval Whiplash: Strong April Follows Terrible March (Pink Sheet-$)
  • Generic Drug Manufacturers Have Less than 1 Month to Self-Identify to FDA (Registrar Corp)
  • Should Congress Set up a "Free to Choose" Approval Track for New Drugs? (Fox)
  • IPEC says confusion around FDA review of excipients could delay ANDA review cycles (In-Pharma)
  • Background Analysis on FDA AdComm on vCJD (Tarius)
  • How 21st Century Cures draft boosts NIH budget, addresses FDA concerns (BioCentury-$)
  • How subgroup data helped FDA panel recommend Amgen's T-Vec in melanoma (BioCentury-$)
  • Generic just as good as brand name when it comes to anti-rejection drug (MJS)
  • Emergent BioSolutions gains US FDA approval for Ixinity (PharmaLetter-$)
  • Zeltia says FDA extends deadline for priority review of Yondelis (Reuters)
  • U.S. Chamber Applauds Enactment of Alabama Law to Correct Supreme Court Prescription Drug Ruling (Press)
  • Alabama Senate Passes Right to Try Bill (Press)
  • Teva Parenteral Medicines Initiates Voluntary Nationwide Recall of Select Lots of Adrucil® (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL) Due to Particulate Matter (FDA)

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

US: Pharmaceuticals and Biotechnology: General

  • Cancer drug spend tops $100bn in 2014 (PMLive) (Fierce) (Reuters) (SCRIP-$)
  • NYTimes Editorial Board Throws Support Behind Medicare Price Negotiation (NYTimes)
  • Pragmatic Aspirin-Dosing Trial Starts Up (MPT)

US: Medical Devices

  • Appeals court rejects case claiming Medtronic's Infuse device harmed patient (StarTribune)
  • FDA Device Center Names New Deputy Policy Director (Gray Sheet-$)
  • Researchers question safety of off-label device use in atrial fibrillation, call for 510(k) review process (Fierce) (MPT) (HealthDay)
  • FDA rejects AcelRx's request for meeting on pain drug device (Reuters)
  • Some Medical Device Companies Leverage Clinical Trials To Supplement FDA Submissions And Enhance Marketing Messages Despite Avoiding Necessity To Complete Them (CuttingEdgeInfo)
  • Johnson and Johnson RCT aims to find out if a diabetes app can improve A1C (MobiHealthNews)
  • FDA Posts Meeting Materials For Upcoming Gastro-Urology AdComm Meeting (FDA)
  • Transcend Medical Announces Intent to File Premarket Approval Application With FDA for the CyPass Glaucoma Micro-Stent (Press)

US: Dietary Supplements

  • FTC Halts Deceptive Marketing of Bogus Weight-Loss Products (FTC) (CBS)

Upcoming Meetings and Events

Europe

  • EMA: Recommendations for Updated Drug Safety Information Nearly Doubled in 2014 (FDAnews-$) (EMA)
  • Market access for specialist medicines in the UK: the Price is Right? (PharmaPhorum)
  • Gene therapy takes step forward as GSK files for EU approval (Reuters)
  • Baxter Bioscience and Merrimack Pharmaceuticals Announce Filing for European Approval of MM-398, an Investigational Treatment for Post-Gemcitabine Metastatic Pancreatic Cancer (Press)
  • Publication of a JA2 methodological guideline - Methods for health economic evaluations (EUnetHTA)

India

  • NPPA warns drug companies over non-registration with online database (IndiaTimes)
  • Maha FDA urges DCGI to take action against online sale of prescription drugs (PharmaBiz)

Japan

  • Japan to adopt CDISC clinical data standards from October 2016 (Fierce)

China

  • China to remove drug pricing controls next month (PharmaTimes) (Reuters) (Fierce)
  • China proposes new rules on safely handling vaccines; detailed company records a must (Fierce)

Canada

  • Health Canada Finalizes Recommendations on Third-Party Data in Drug Submissions (FDAnews)
  • Better documentation of adverse drug reactions needed for new Bill C-17 to improve drug safety (MNT) (CBC)

Australia

  • Prescription medicines: registration of new chemical entities in Australia (TGA)

Other International

  • API firms stand to gain by seeking prequalification says the WHO (OutsourcingPharma)
  • Saudi FDA Approves Abbvie's HepC Drug, Viekirax (SaudiGazette)

Clinical Trials

  • Researchers call for further ethical discussions of adaptive clinical trials (Outsourcing-Pharma)

General Regulatory And Interesting Articles

  • A step toward making everybody a universal blood donor (WaPo)

Regulatory Reconnaissance #550 – 5 May 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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