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...

Pharmaceutical (drug and biologic) and medical device companies today are challenged with a stringent and continually evolving regulatory environment, together with changing technologies and global economic considerations. Regulatory Affairs is a very important part of regulated industries that manufacture products intended for human use. One such and also the most important is the pharmaceutical industry. Any product cannot enter the market unless and until it is authorized by the concerned regulatory authority. In 1937, Elixir Sulfanilamide which was marketed without any marketing testing caused deaths of more than 100 people in the USA. The pharmaceutical company added DEG as a solvent along with raspberry flavor for Sulfanilamide to be used as an elixir. This created an outrage and finally, led to the Federal Food, Drug and Cosmetic Act in 1938. However, the tragic incidents did not end there, there were many which led to various acts and amendments and one of the impactful ...

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...

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 ...

Good Documentation Practices are the soul of many regulated industries. The FDA, like all other regulatory agencies, makes GDP a central element of its regulations, and bases it on the principle of evidence. For the FDA and other regulatory agencies across the world, what is not documented is nonexistent. Good documentation practice  (commonly abbreviated  GDP , recommended to abbreviate as  GDocP  to distinguish from "good  distribution  practice" also abbreviated GDP) is a term in the  pharmaceutical and medical device industries  to describe standards by which  documents  are created and maintained. What to write, and how to GDP should not only be about just writing down; it is about what to write and also, how, meaning, in what manner. If there has been an intervention in any method of manufacture or any other activity in the regulated industries; the change should be noted down in the proper format as prescribed by the FD...