• Feature ArticlesFeature Articles

    Latin America market opportunities for food supplements: Navigating regulatory complexities

    This article discusses the growth opportunities in Latin America for food supplement businesses. It provides guidance for companies eager to interpret current regulation, predict future direction, and plan successful commercial strategies. The author addresses the commercial advantages going along with increased regional and global harmonization and how to navigate current regulatory complexities to realize commercial opportunities and meeting the challenges and opportunit...
  • Regulatory NewsRegulatory News

    Updated: Copaxone Generics: Who Will Win First Filer Exclusivity?

    Generic versions of Teva's multi-billion-dollar per year multiple sclerosis drug Copaxone (glatiramer) have arrived, but a closer look at which competitor might win the coveted 180-day exclusivity reveals an unusual and complex situation. Back in January, a US District Court for the District of Delaware ruling invalidated all asserted claims  on Teva's patents on its 40 mg version of Copaxone, opening the door for generic competitors. Late Tuesday, Mylan  announce...
  • Regulatory NewsRegulatory News

    German Regulators Slam Dr. Reddy's Plant for Critical, Major Deficiencies

    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. The non-compliance report calls out the site, which manufactures and packages non-sterile capsules and tablets, for one critical deficiency related to the essential elements of its...
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    FDA Calls Out Unproven Claims of Unapproved Blood Device

    Earlier this month, the US Food and Drug Administration (FDA) released a letter sent to Dr. PRP America for claims made on its website for an unapproved medical device that the San Diego-based company claims can help concentrate and extract blood platelets, as well as adjust blood plasma levels. Mary Malarkey, director of the Office of Compliance and Biologics Quality at FDA’s Center for Biologics Evaluation and Research, wrote in the letter that a review of FDA’s databa...
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    Senate Confirms Califf as Next FDA Commissioner

    The US Senate on Tuesday voted 89 to 4 to confirm Robert Califf to be the next commissioner of the US Food and Drug Administration (FDA). Califf's path to confirmation was made clear after a procedural vote Monday evening, when senators voted 80 to 6 to move the nomination to a vote. In September, President Barack Obama nominated Califf to replace Margaret Hamburg, who resigned in March after leading FDA for six years and was replaced in th...
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    FDA Warns Sandoz, Dr. Reddy’s Indian Sites Over Data Integrity Violations

    Serious data integrity violations, including the backdating of records and failing to provide pertinent data to regulators, were included in warning letters for five manufacturing facilities from both Sandoz and Dr. Reddy’s in India, according to the US Food and Drug Administration (FDA). Both companies previously disclosed receiving the FDA warning letters in October and November, though the contents of the violations were not released until now. And like a number of ...
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    South American Health Ministers Negotiate Lower Prices for Antivirals, Antiretrovirals

    As the drug pricing debate continues in the US, the ministers of health of 10 Latin American countries recently persuaded pharmaceutical companies to lower the prices of several HIV/AIDS and hepatitis C treatments. In the first of two planned rounds of negotiations, the health ministers of MERCOSUR (which includes Argentina, Bolivia, Brazil, Paraguay, Uruguay, Venezuela and associate countries Chile, Peru, Colombia and Ecuador) earlier this week agreed to purchase the HI...
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    Dr. Khoo Teng Chuan, Co-Chair of the RAPS Pan Asia Advisory Committee, Dies at 56

    Dr. Khoo Teng Chuan, a leader and expert in the pharmaceutical and medical device sectors across Asia, passed away on Tuesday at the age of 56. Most recently, Dr. Khoo worked as chief medical officer for the Singapore Clinical Research Institute, after joining the institute as senior vice president in 2010. In this role as chief medical officer, he worked closely with Singapore’s national agencies including the National Medical Research Council, Health Sciences Aut...
  • Feature ArticlesFeature Articles

    Considering a Business Presence in Latin America? What You Should Know about Regulatory in the Region

    When considering expanding or relocating to Latin America, companies typically focus on business decisions. Should an office be established in each country or should business be done through local distributors? Often, companies neglect to design a specific regulatory strategy, even though regulatory issues are an important element in an effective business plan. Challenges to Latin American Marketing There are many reasons a company should consider regulatory the ...
  • Brazil Pushes Ahead With New Environmental Protection Plan Focused on Drug Disposal

    Brazil's Ministry of Environment (MMA) has issued a final deadline for the pharmaceutical industry to submit its own proposal on how to implement an agreement intended to ensure the environmentally sound disposal of medicines and packaging after use by consumers. The 2010 sectoral agreement requires industry to implement the mandated drug disposal measures within five years in all cities with more than 100,000 inhabitants. This is the third deadline set by the govern...
  • Brazilian Legislators Looking for Enhanced Role in Multi-Country Clinical Trials

    At a hearing on enhancing pharmaceutical research in Brazil, the chair of the Senate Social Affairs Committee, Senator Waldemir Moka, called for the creation of a working group of government agencies and academic researchers who would prepare proposals on ways to bring multi-country clinical trials to Brazil.  Another Senator, Ana Amelia, noted the possible need to revise the existing legal framework governing the conduct of clinical trials in the country, if nec...
  • Brazil Establishes Contingency Process for Dealing With EU API Export Rules

    Under a new plan announced by Brazil's regulatory agency, Anvisa, even if Brazil fails to obtain EU recognition for its active pharmaceutical ingredient (API) good manufacturing practice (GMP) standards by the mandatory date of 2 July 2013, regulators will still provide Brazilian companies with a document indicating GMP compliance so facilitate exports of their APIs. The Falsified Medicines Directive (Directive 2011/62/EU) was adopted in May 2011 to safeguard public he...