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...

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...

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 ...

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...