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April 2, 2013
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News on diagnostic and therapeutic innovations and regulatory science

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  Asia Pacific 
  • Price ceilings for drugs in India could be set from the start
    The Indian government is weighing limits on drugs prices as they reach market. A government official said drugmakers could be required to get a pricing OK before sales begin. "The idea is to ensure companies do not gold-plate drugs to exorbitantly increase prices while introducing those in the market," the official said. Business Standard (India) (4/1) LinkedInFacebookTwitterEmail this Story
  • Expanding Japanese market entices Indian pharmaceutical firms
    India-based makers of active pharmaceutical ingredients have made inroads in the Japanese market, with seven APIs approved in Japan for Dishman Pharmaceuticals alone. Indian generic-drug makers also hope to penetrate the market as the Japanese government promotes the use of generic drugs through tax and social security reform. Business Standard (India) (3/31) LinkedInFacebookTwitterEmail this Story
  North America 
  • U.S. balances drug patent protection, poor's access at TPP
    The U.S. is trying to ensure both the poor's access to drugs and strong patent and data protections for drugmakers in the Trans-Pacific Partnership, according to Deputy Assistant U.S. Trade Representative Probir Mehta. The U.S. will seek common ground but won't have a new proposal involving pharmaceuticals when TPP talks renew in Peru in May, Mehta said. Persuading partner nations of the benefits of strong intellectual property rights is hard when U.S. nongovernmental organizations present contrary information, said Ron Kirk, a former U.S. trade representative. Many generics are available in TPP nations, PhRMA's Jay Taylor said. "The TPP, if done correctly, should reduce tariffs and extra additive costs to medicines that ultimately hurt patients," he said. Reuters (3/28) LinkedInFacebookTwitterEmail this Story
  Latin America 
  • Brazil plans to streamline health care product approval
    Brazil's health ministry announced plans to speed approval and registration of health care products. Anvisa, the country's health care products regulatory agency, plans to expand its technical staff, open an electronic registration application system for drugs, allow partner agencies to inspect foreign manufacturers and recognize inspections by other agencies or certification bodies. Clinica (subscription required) (3/28) LinkedInFacebookTwitterEmail this Story
  • Booz: Pharma should take individual approach to emerging markets
    A new analysis from consultant Booz & Co. notes that emerging markets may not be as lucrative for pharmaceutical companies as they hope. While pharma companies that enter these markets early can help shape them, the report noted that the size of countries classified as "emerging markets" varies, and the "ambitious targets" of some companies have not be met. "Companies should be aware that whilst there is huge potential here, variations within the emerging markets themselves require different and tailored approaches," the report cautions. PharmaTimes (U.K.) (3/28) LinkedInFacebookTwitterEmail this Story
  • Participants not using adverse-events system correctly, survey finds
    The national competent authorities report program is being used by international stakeholders to communicate corrective actions for medical devices found to be at risk, but not to exchange information on serious adverse events or risk assessments on which corrective actions are based, a survey conducted by the International Medical Device Regulators Forum found. The survey also found that information is sometimes exchanged too late, and some participants do not contribute information at all. The stakeholders surveyed suggested ways to improve the system, such as including data from registries as well as unfavorable findings from pre-market evaluations. Clinica (subscription required) (3/28) LinkedInFacebookTwitterEmail this Story
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