Tuesday, 26 June 2018

Regulatory Affairs


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 (pharmaceuticalsmedical devicesbiologics 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 Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking).
·         Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance
Healthcare RA
The regulatory function in healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products, including:
·         pharmaceuticals
·         medical devices
·         in vitro diagnostics
·         biologics and biotechnology
·         nutritional products
·         cosmetics
·         veterinary products

The regulatory professional's roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising and postmarket surveillance.
Core competencies
Regulatory professionals come from diverse backgrounds. Most regulatory professionals have earned a bachelor's degree, and more than half have an advanced degree, most often in a scientific or technical field. In addition, regulatory professionals usually have experience in other careers before transitioning into regulatory affairs.
Although there are some university degree and graduate certificate programs in regulatory affairs and related areas, experience is a key asset for regulatory professionals. Valuable skills include project management and organization, negotiation and communication, and the ability to learn from the experience of others, both inside and outside the organization.
Continuing education and professional development are critical to the regulatory professional. Regulatory professionals must keep up to date with regulatory policies and procedures for one or more countries, as well as maintain an understanding of the scientific and technical background of healthcare products. Global aspects of regulatory affairs are taken up by organisations such as the Drug Information Association (DIA) and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
Origins
The healthcare industries were the first to be significantly regulated in the modern era. Much of this regulation has stemmed from avoiding the repetition of disasters, and has tended to be led by the USA due to size of the market and its technological lead
·         Diphtheria Epidemic led to 1902 Biologics Control Act
·         Publication of The Jungle by Upton Sinclair led to 1906 Pure Food and Drugs Act
·         Elixir of Sulfanilamide led to the 1938 Food Drug and Cosmetic Act
·         Thalidomide led to the 1962 Kefauver Harris Amendments
·         Dalkon Shield led to the 1976 Medical Device Amendments
·         Bjork-Shiley Heart Valves led to the 1990 Safe Medical Devices Act
In the USA, this regulation is largely written directly into law and codified in Title 21 of the Code of Federal Regulations
Recent developments
Starting in 1980 the European Union started to harmonize the regulation of healthcare products in the member states. The concept of regulating medicines was well established in most member countries along similar lines to the US model, but many countries did not have any significant medical device regulation. Concurrently the EU had been developing the concept of New Approach Directives where only broad concepts were written into the law and the bulk of the technological detail delegated to compliance with recognized standards (which are more readily update-able).
The Europeans took the radical approach of applying the New Approach Directive to Medical Devices and by doing so made the first significant conceptual advance in healthcare regulation for nearly 100 years.
The European Model for medical device has largely been adopted by the Global Harmonization Task Force as the international template
Future developments
Many in the Regulatory Affairs Profession believe the New Approach to regulation will eventually be adopted for all healthcare products as it represents the best model for delivering new healthcare advances to market in a reasonable time with acceptable safety.
Regulatory Affairs departments are growing within companies. Due to the changing resources necessary to fulfill the regulatory requirements, some companies also choose to outsource or outtask regulatory affairs to external service providers. Regulatory Affairs department is constantly evolving and growing and is the one which is least impacted during the Acquisition and Merger, and also during recession. Global harmonization in standards has led to consistent approach in regulatory submissions and hence its review.
Regulatory affairs profession
The (healthcare) regulatory affairs profession is still an emergent profession but has four major international professional membership organizations:
·         Drug Information Association, DIA, link 
·         The Regulatory Affairs Professionals Society, RAPS, link
·         The Organisation for Professionals in Regulatory Affairs, TOPRA,link
·         Association of Regulatory Affairs Professionals,ARAP India, link
·         Vietnam Regulatory Affairs Society: link
which offer education and training, professional development, competence certification and codes of ethics.
The regulatory professional typically has a background relevant to the business in which they work, i.e., science, medicine, or engineering.

Friday, 8 June 2018

Product list updated

Product List

Pharma ACTD dossiers is the leading company in pharma regulatory pocesses.At start we were having about 150-200 products but as we are growing now the list has increased to 1000+ products. All the documents of the products in the product list are updated and are ready to use.

please see our product list


http://www.pharmaactddossiers.com/list-of-ready-dossiers/

Dossiers

Our dossiers are compositions of the data most crucial in gaining a strong foothold in a subject area. We compile our dossiers in accordance with the most recent researches and according to client's requirements.These dossiers contain links to the most important information about a certain topic, they are not exhaustive lists of everything that has appeared online.

We undertake the full project i.e after careful market survey we select products of priority for registration and also provide complete regulatory support till the registration stage


  • Company registration in getting brand search and registered wherever mandatory.
  • Preparation of medical dossiers for registration of medical products.
  • Translation of Medical dossier into the local language before submission of documents to the Health Ministry for product registration.
  • Handling query if any on your behalf
  • Execution of registration process until the procurement of registration certificates.

company website



Saturday, 2 June 2018

Drug approval process in European countries

       CP Centralised Procedure


Marketing authorisations granted under the "centralised procedure" allow the marketing-authorisation holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorisation.Under the centralised procedure, a company may only obtain one marketing authorisation per medicinal product. However, in specific cases a company may apply for a duplicate marketing authorisation. Requests to submit an application for a duplicate should be sent to the Commission DCP Decentralised Procedure

An identical application for marketing authorisation is submitted simultaneously to the competent authorities of the Reference Member State and of the Concerned Member States. At the end of the procedure, the draft assessment report, SPC, labelling and package leaflet, as proposed by the Reference Member State, are approved.
The subsequent steps are identical to the mutual recognition procedure.
The mutual recognition procedure (MRP) is a European authorisation route resulting in a mutually recognised product.
Mutual recognition must be used when a product is already authorised in at least one Member State on a national basis and the Marketing Authorisation Holder wishes to obtain a Marketing Authorisation ( MA ) for the same product in at least one other Member State.
The Member State that has already authorised the product is known as the Reference Member State (RMS). The RMS submits their evaluation of the product to other Member State/s, these are known as Concerned Member States (CMS). The CMS is asked to mutually recognise the MA of the RMS.
If the applicant is successful, the CMS will then issue a MA for that product permitting the marketing of that product in their country.
The majority of medicines available in the EU were authorised at national level, either because they were authorised before EMA’s creation or they were not in the scope of the centralised procedure.
Each EU Member State has its own national authorisation procedures.

(AP) Authorisation procedures

(MRP)Mutual Recognition Procedure

(NP) National procedure

for more enquiries please visit our Website

Europe’s new data protection rules



Europe wants to conquer the world all over again.
Only this time, its killer app isn’t steel or gunpowder. It’s an EU legal juggernaut aimed at imposing ever tougher privacy rules on governments and companies from San Francisco to Seoul.
When the region’s regulators roll out the changes — known as the General Data Protection Regulation, or GDPR — on May 25, it will represent the biggest overhaul of the world’s privacy rules in more than 20 years.
The new regulations offer EU citizens sweeping new powers over how their data can be collected, used and stored, presenting global leaders outside the 28-country block with a stark choice: bring their domestic laws in line with the EU’s new rules, or risk being shut out of a market of 500 million well-heeled consumers.
“Data protection is a good example of Europe trying to extend its influence over other countries,” said Christopher Kuner, co-chair of the Brussels Privacy Hub at the Vrije Universiteit Brussel. “Call it the ‘Brussels Effect.’”
For many countries, the choice is a no-brainer. Breaking commercial ties with the world’s largest trading bloc is unthinkable, and failing to comply brings the risk of hefty fines — up to €20 million or 4 percent of global revenue, whichever is higher — for any company with European customers that mishandles data.
In response, legislators worldwide are scrambling to update their domestic legislation to bend to Europe’s privacy rules. The data revamp will allow EU consumers to pull their data from a company at any time, force businesses to alert customers within three days if their data is hacked and let people move information to rival services at a drop of a hat.


The “Brussels effect” is mostly manageable for advanced economies like Japan, which last year set up an independent agency to handle privacy complaints to conform with Europe’s privacy standards during negotiations for a new Japan-EU trade deal.
But for emerging countries, the cost and administrative burden of applying the EU privacy standards can be daunting. In countries like South Africa, whose domestic legislation is primarily based on Europe’s rules, the upcoming data protection changes risks being viewed as yet another diktat handed down by former colonial powers in a form of “data imperialism.”
“Any country that’s not working toward these standards is left out in the cold,” said John Giles, managing attorney at Michalsons, a law firm in South Africa. “GDPR has long tentacles.” 

HAPPY-NEW-YEAR