Pharma ACTD Dossiers

Counterfeiting A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/ or source.  Counterfeiting of medicines can apply to both branded and generic products. Generally, counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with in correct quantities of activities ingredients or with fake packaging  Counterfeit Medicines Products marketed with intent to deceive 1– Counterfeit active/bulk ingredients 2– Counterfeit finished products 3– Unregulated diverted products 4– Counterfeit labeling 5– Mislabeled substances (e.g., generic anti-biotics) Why are Medicines a Target? Fakes can be made relatively cheaply (at least as profitable as narcotics – lower risk). Many countries, especially in the developing world lack adequate regulation and enforcement Even in the industrialized countries, the risk of prosecuti

South Africans need to return 318,000 packets of potentially dangerous pills The South African distributor of heart pills that may contain a potentially carcinogenic ingredient has confirmed that more than 318,000 packets of pills may be affected. “Operationally, it is a difficult situation,” a representative of Pharma Dynamics, the distributor of the tablets in South Africa, told Business Insider South Africa. The South African Health Products Regulatory Authority (SAHPRA) this week recalled Dynaval Co high blood pressure and heart pills, which may contain a controversial carcinogenic ingredient that was manufactured in China. Dynaval Co 80/12.5 mg, 160/12.5 mg and 160/25 mg pills, which were manufactured by Zhejiang Huahai Pharmaceuticals, may contain the chemical NDMA. NDMA is associated with liver damage and liver cancer in rats as part of laboratory tests, says dr Eric Decloedt, a clinical pharmacologist at the department of medicine of the University of Stelle

Pharma regulatory intelligence Less complexity. More clarity. Regulatory intelligence refers to the process of gathering, monitoring and analyzing regulatory information and data to track developments in the changing regulatory environment. Banking, financial services, and insurance sectors continue to experience unprecedented volumes of regulatory change and complexity. Our unique one-stop Regulatory Intelligence provides world-class content and advanced technology that cuts through the complexity and the sheer volume of content and developments within the regulatory compliance environment. That’s how we can provide clarity on what is most important to your organization –  in a cost effective way. Unsurpassed breadth, depth and quality Regulatory Intelligence includes global coverage of over 900 regulatory bodies and more than 2,500 collections of regulatory and legislative materials. It is powered by exclusive news, analysis, and practical guidance from our glob