September 26th 2025
The 100% tariff on imported drugs will pressure pharma companies to build manufacturing sites in the US or face significant costs.
Enforcing GMP compliance for APIs in EU medicines
June 1st 2007The Active Pharmaceutical Ingredients Committee (APIC) - a sector group of Conseil European des Federations de l'Industrie Chimique (CEFIC) - first voiced the need for EU GMP API legislation in 1993 to help ensure the safety of medicines. In 2000, the International Conference on Harmonisation (ICH) finalized the harmonized API GMP Guideline Q7, which became legal in the US and Japan in 2001. The EU adopted a directive in March 2004 that includes the requirement for APIs in medicines for the EU market to comply with ICH/Q7A. Member States are transposing the directive into their national law: about half of them have completed this process, seven more are well on their way to completion, while seven others are still in earlier stages of adoption.
Securing the Chain of Custody in the Pharmaceutical Supply Chain
April 27th 2007Interphex2007, New York, NY (Apr. 26)-Counterfeit medicines are of increasing concern to the pharmaceutical industry, both because of the potential health risks to patients and because of the effects on pharmaceutical companies' businesses. While technology such as e-pedigree and radio frequency identification (RFID) represent solutions to secure the supply chain, there are challenges.
Cracking Down on Counterfeiting
August 2nd 2006Disappointed in progress thus far, the US Food and Drug Administration wants pharmaceutical manufacturers to make a greater effort to combat counterfeit products and recommends that they "move quickly" to implement radio-frequency identification technology.
MHRA Renews Recall of Counterfeit Lipitor
July 27th 2006The UK Medicines and Healthcare Products Regulatory Agency (MHRA, London) has reissued its recall of a specific batch of counterfeit ?Lipitor? 20-mg tablets. MHRA, in conjunction with Pfizer (New York City, NY), first issued the recall of batch number 004405K1 in July 2005. The new recall is in response to the discovery of more packages of the counterfeit drug in the United Kingdom.
Supply Chain Technology, Real-Time Quality System Win Microsoft Awards
June 22nd 2006Microsoft Corporation (Redmond, WA) announced the winners of the Microsoft Pharmaceuticals and Life Sciences Innovation Awards 2006 at this year?s meeting of the Drug Information Association in Philadelphia, Pennsylvania. A four-person panel of industry experts selected winners for the innovative use of Microsoft products in pharmaceutical and life sciences business processes and practices.
FDA to Strengthen Fight Against Counterfeit Drug Products
June 15th 2006The US Food and Drug Administration?s Counterfeit Drug Task Force (Rockville, MD, www.fda.gov) is recommending regulatory actions and the implementation of new technologies for reducing the risk of counterfeit drugs entering the United States. The group has followed up on its original 2004 report, in which it outlined the framework for protecting the public from counterfeit medicines, and an updated 2005 report with a third document encouraging electronic pedigrees, improved traceability in the drug supply chain, and the adoption of radio-frequency identification (RFID) tools.