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...

If we will search for  RI  anywhere we will be getting many results and definitions. The act of gathering and analysing publicly available regulatory information. This includes communicating the Implications of that information, and monitoring the current regulatory environment for opportunities to shape future  regulations , guidance, policy and legislation. Regulatory Information collectively comprises of three main segments which are followed while performing Regulatory Information activities: •  Gather Data : RI professionals perform research about regulatory norms as per a particular product in a particular geography. As far as collecting relevant regulatory information is concerned, there are a lot of sources that RI professionals leverage to consolidate their research material. •  Analyse Information : This gathered data needs to be filtered out to obtain relevant information as per the purpose. The data filtered is then rearran...

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 ...

In general,  compliance  means conforming to a rule, such as a specification,  policy , standard or law.  Regulatory compliance  describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations. Due to the increasing number of regulations and need for operational transparency, organizations are increasingly adopting the use of consolidated and harmonized sets of compliance controls. This approach is used to ensure that all necessary governance requirements can be met without the unnecessary duplication of effort and activity from resources. Regulations and accrediting organizations vary among fields, with examples such as PCI-DSS and GLBA in the financial industry, FISMA for U.S. federal agencies, HACCP for the food and beverage industry, and the Joint Commission and HIP...

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...