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...

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...

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...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Abbott Contests Indian Allegations of Substandard Cough Syrups A dispute between Abbott and regulators in India has raised doubts about the effectiveness of the quality testing regimens implemented by local authorities. The case centers on a sample of a product branded as Abbott’s cough syrup Phensedyl that was found to contain twice as much codeine as was listed on t...

Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. South Korea’s medical device market regulator, the Ministry of Food and Drug Safety (MFDS), will begin requiring clinical data for dozens of medical devices in January 2016 that currently can avoid such requirements if their equivalence to predicate devices already on the South Korean market can be shown. Among the  proposed list of devic...

Africa has a rapidly growing populace and demand for safe, effective and trusted medical products. Different geographic areas of Africa are developing their medical products submission and approval systems at varying rates of sophistication dependent, in part, on internal resources. Exclusively for RAPS members comes this valuable collection of articles exploring important regulatory differences in five major geographic/economic regions of Africa: East and Southe...

Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. South Korean medical device regulators will implement significant changes affecting compliance requirements for  in vitro  diagnostic (IVD) registration as well as for Korean Good Manufacturing Practice (KGMP) audits over the course of 2015. According to Emergo consultants in Seoul, officials at the South Korean Ministry for Food and Drug...

South Africa’s medicines’ regulatory submission process is well governed, and there are numerous guidelines available, many following EU standards. The pharmaceutical regulating body in South Africa, the Medicines Control Council (MCC), is staffed to review a dossier completely to international standards, and it conducts its own review of the complete dossier, regardless of other major regulatory approvals (See Table 1 for MCC contact information). In ...

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'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...

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...

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...