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 ...

Certificates of Analysis (CoA) World’s future of business is in outsourcing and globalisation EU GMP Guide Part I (Chapter 4 and Chapter 6) - these chapters contains detailed information about safety and quality, Laboratory documentation should follow the principles given in Chapter 4. EU GMP Guide Part II - Section 11.4 – §         Authentic Certificates of Analysis should be issued for each batch of intermediate or API on request. §         Information on the name of the intermediate or API including where appropriate its grade, the batch number, and the date of release should be provided on the Certificate of Analysis. For intermediates or APIs with an expiry date, the expiry date should be provided on the label and Certificate of Analysis. For intermediates or APIs with a retest date, the retest date should be indicated on the label and/or Certificate of Analysis. §  ...

What Is The Registration Process For Exporting A Drug In Different Countries? Exporting drugs to different countries depends on the regulatory system of the both the courtiers. Import and export of drugs from a pharmaceutical industry are allowed after gaining all the approvals. Earlier in India, the export of drug was not a cumbersome process but, now the Indian regulatory system is too fragile. It takes about a year or so for a drug to be approved for marketing. The ever-changing laws, regulations, and demand have completely tossed the approval process. The Central Drugs Standard Control Organisation of India controls the import and export of pharmaceutical products. Drug Registration Process Drug registration is a system meant for all the pharmaceutical products. It is required for pre-marketing evaluation, marketing authorization, and post-marketing review so as to ensure that all the products fall in the standards of quality, safety, and efficiency. In short, drug reg...

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...