Pharma ACTD Dossiers

👽REGULATORY BODIES👽 A R egulatory Body    (also  regulatory authority ,  regulatory  agency  or  regulator ) is a  public authority  or  government agency  responsible for exercising autonomous authority over some area of human activity in a  regulatory  or supervisory capacity. An independent regulatory agency is a regulatory agency that is independent from other branches or arms of the government. Regulatory authorities are commonly set up to enforce safety and standards, and/or to protect consumers in markets where there is a lack of effective competition or the potential for the undue exercise of market power. Examples of regulatory agencies that enforce standards include the  Food and Drug Administration  in the United States and the  Medicines and He...

Recently, the FDA declared that it was no longer accepting applications for generic formulations of Oxycontin . The reason? Because Purdue Pharma, OxyContin’s manufacturer, had developed–and received approval for–an “abuse-resistant” formulation of the drug. Whether this is an example of regulatory gamesmanship or the fruits of incentivizing public safety is up for debate. With that in mind, the CLB blog is proud to host a short debate between CLB Fellow, Jake Sherkow, and Duquesne School of Law Professor, Jacob Rooksby. The FDA’s determination is sensible. It recognizes the original OxyContin®’s abuse limitations and the attendant public safety risks of allowing generic versions of the original drug to enter the market. OxyContin® (oxycodone hydrochloride) quickly became the market leader in the burgeoning field of chronic pain management when the FDA approved it for sale in late 1995. Touted for its patented sustained-release properties, OxyContin® a...

       Future of pharma outsourcing The pharmaceutical industry’s main markets are under serious pressure. North America, Europe and Japan jointly account for 82% of audited and unaudited drug sales; total sales reached US$773 billion in 2008, according to IMS Health. Annual growth in the European Union (EU) has slowed to 5.8%, and sales are increasing at an even more sluggish rate in Japan (2.1%) and North America (1.4%).1 Impending policy changes, promoting the use of generics in these key markets are expected to further dent the top- and bottom-line of global pharma majors. The industry is bracing itself for some fundamental changes in the marketplace and is looking at newer ways to drive growth. More than that, India has a growing pharmaceutical industry of its own. It is likely to become a competitor of global pharma in some key areas, and a potential partner in others. India has considerable manufacturing expertise; Indian companies are among the wor...

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 ...

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 St...

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 expertise in global drug development uniquely qualifies us as the provider of a variety of medical and regulatory services.It is important to have these local contacts so as to maximise the chance of a successful outcome in terms of a client’s regulatory strategy and/or licence submission. Our professionals are all very experienced with many of them being leaders in their own field. As a direct result of the high calibre of our professionals, we are able to provide strategic advice (thinking ‘outside the box’) as well as ensuring compliance with all the current and relevant rules and regulations. Medical and Clinical Consulting Consulting on the Complete Product Development Program (all phases) Reviewing and Assessing Clinical Protocols Reviewing Safety and Efficacy Related Issues During Product Development Adjudicating Clinical Data Worldwide Drug Safety and Pharmacovigilance Services Clinical Trial Safety Services Post-Marketing Surveillance Services Pharmacovigilance ...

GMP- GOOD MANUFACTURING PRACTICES Good manufacturing practices  ( GMP ) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of  food  and  beverages ,   cosmetics ,   pharmaceutical products ,  dietary supplements,  and  medical devices . All guideline follows a few basic principles: Manufacturing facilities must maintain a clean and hygienic manufacturing area. Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use. Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications. Manufacturing processes must be controlled, and any changes to the pro...

Regulatory affairs Regulatory affairs  ( RA ), also called  government affairs , is a profession within regulated industries, such as pharmaceuticals, medical devices, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare industries ( p harmaceuticals ,  medical devices ,  biologics  and  functional foods ). Regulatory affairs  (medical affairs) professionals (aka regulatory professionals) usually have responsibility for the following general areas: ·          Ensuring that their companies comply with all of the regulations and laws pertaining to their business. ·          Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business, i.e., working with such agencies as the  Food and Drug Ad...