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  • FDA Sets Facility Registration Fees for Manufacturers of Generic APIs, Finished Dosage Forms

    • 16 January 2013
    The US Food and Drug Administration (FDA) has published the user fee rates for facilities that manufacture active pharmaceutical ingredients (APIs) and finished dosage forms (FDF) for the current fiscal year, part of the agency's new authority under the FDA Safety and Innovation Act (FDASIA) . In July 2012, FDA was for the first time given the authority to collect user fees from facilities and manufacturers of generic drug products, including those making just the act...
  • EU Falsified Medicines Directive Could Result in Drug Shortages

    The European Heads of Medicines Agencies (HMA) has notified the European Commission of its "deep" concern that the implementation of the Falsified Medicines Directive (2011/62/EU) will lead to possible shortages of medicinal products with resulting risks to public health.   The Directive, which goes into effect on 2 July 2013, requires all imported active pharmaceutical ingredients (APIs) to be manufactured in compliance with the standards of good manufacturing pr...
  • Health Canada Announces Adoption of New GMP Standards for Active Ingredients

    Canadian public health officials have announced the expansion of Health Canada's regulatory authority to inspect and require all active ingredients(AIs)-sometimes referred to as active pharmaceutical ingredients (APIs)-to meet current good manufacturing practice (CGMP) standards. The change in some ways reflects a change in the way pharmaceutical products are now manufactured. Many facilities will manufacture just AIs or APIs, sending the finished product to a second man...
  • Trade Group Calls for Mutual Inspection Regime to Safeguard API Supply Chain

    • 13 November 2012
    The European Fine Chemical Group (EFCG) , an industry association of chemical manufacturers-including more than 150 devoted to pharmaceutical manufacturing-is calling for mandatory inspections of all global active pharmaceutical ingredient (API) manufacturing sites through the use of mutual recognition agreements. In a 12 November statement, EFCG said it was, "Proposing a global harmonization of the rules and regulations governing the manufacture of APIs to level the wo...
  • ICH Working Group Calls for Revisions to Q7 Guideline

    The International Conference on Harmonisation (ICH) has published a new concept paper regarding the standardized regulation of good manufacturing practices (GMPs) for active pharmaceutical ingredients (APIs), the first step in reforming the organization's Quality 7 (Q7) Guideline. The paper, endorsed by ICH's Steering Committee in October 2012 and released in November 2012, refers to the widely-used Q7 GMP Guidance for APIs , released in November 2000. The document, I...
  • FDA Wants Supply Chain Security Pilot Program to Continue

    Call it ironic timing. On the same day Congress announced the removal of a pharmaceutical supply chain protection system from the pending Food and Drug Administration Amendments Act (FDAAA) , the US Food and Drug Administration (FDA) announced it is looking to continue a supply chain protection pilot program. The initiative, called the Secure Supply Chain Pilot Program, was launched in January 2009 with the intent of better securing finished pharmaceutical products ...
  • USP Releases Overhaul of Impurities Testing Standards

    • 24 May 2012
    The US Pharmacopeia (USP), a standards-setting body for the content of medicines, has released two new standards to limit the presence of elemental impurities in medicinal products. The standards, <232> Elemental Impurities - Limits and <233> Elemental Impurities - Procedures , outline procedures on how to detect common impurities and sets limits on the presence of impurities to protect consumers from exposure. "Elemental impurities can occur naturally, b...
  • Hamburg Calls for New Authority, Strengthened Anti-Counterfeit Laws

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said in a statement she believes existing pharmaceutical anti-counterfeiting laws are grossly inadequate to deter illicit activity, saying counterfeiters deserve "more severe consequences." Hamburg's 10 April statement on FDA Voice , FDA's blog, made clear she believes the Federal Food, Drug and Cosmetic Act (FD&C Act) is outdated. "[The FD&C Act ] was enacted in 1938, long before there was a...
  • IOM: Boost Foreign Regulatory Capacity to Ensure Drug Safety

    A new report from the Institute of Medicine (IOM) concludes the US Food and Drug Administration (FDA) needs to make investments into advancing the regulatory capacity of developing low- and middle-income nations in order to secure the pharmaceutical supply chain and safeguard the American public. The report, Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad , recommends 13 steps FDA and other regulatory bodies can take in the next five ...
  • Global API Inspection Scheme Continues to Ramp Up, Calls for Additional Members

    An active pharmaceutical ingredient (API) inspection program involving many of the world's premiere global regulatory bodies announced recently its intent to standardize the inspection schemes of the member nations and advance "administrative simplification." The as-yet-unnamed program, which includes the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Australia's Therapeutic Goods Administration (TGA), the World Health Organization (WHO), the...
  • Australia Proposes Ongoing API Inspection Cooperation

    Australia's Therapeutic Goods Administration (TGA) said 2 March that it is working to establish "an ongoing collaboration in international inspection of [Active Pharmaceutical Ingredient (API)] manufacturers and [an] increase in the number of regulators participating" in their good manufacturing practice (GMP) pilot program. TGA noted that this collaboration has resulted in a governing document for the program, which will allow the World Health Organization to become a n...
  • Journal: Counterfeit Market Doubling, Risking Supply Chains

    A report in the International Journal of Clinical Practice has found that the market for counterfeit pharmaceuticals has "doubled in the last five years to more than $75 million," reports Medical News Today . The reports notes that the increase is threatening the integrity of secure supply chains-an issue that came to prominence last week as counterfeit copies of the oncology drug Avastin were found in the US . Many of the counterfeit drugs don't contain the active...