Market Analysis - Regulatory Affairs 2017
Regulatory Affairs Department is the backbone of Pharmaceutical Industry. It is the revenue generator for pharmaceutical Industry. The Regulatory Affairs department is an important part of the pharmaceutical companies.
More than 15 years span is required to develop and launch a new pharmaceutical product in the market. The Regulatory Affairs Agencies explains expenditure spent on each drug annually is $850 million in US. The Indian Pharmaceutical industry is one of the fastest growing industries in India, with a compounded annual growth rate (CAGR) of over 13 % in last 5 years and it is expected to grow at a higher rate in coming 10 years India spends around $300 million, united kingdom $700 , Brazil $200 million , France $550, Italy $400 As per cabinet decision in June 2010 in Japan amended a new policy i.e., Health power strategy through “Life Innovation” and expenditure spent on each drug was $450 million.
Global regulatory affairs outsourcing Industry 2016 report has Forecasted Compound Annual Growth Rate (CAGR) in % value for particular period for regulatory affairs outsourcing market that will help user to take decision based on futuristic chart. Report also includes key players in global regulatory affairs outsourcing market. The regulatory affairs outsourcing market size is estimated in terms of revenue (US$) and production volume in this report. Whereas the regulatory affairs outsourcing market key segments and the geographical distribution across the globe is also deeply analyzed. Recent findings by Transparency Market Research state that the global regulatory affairs outsourcing market will exhibit a healthy 11.5% CAGR from 2015 to 2023. As a result, the market, which had a valuation of US$1.9 billion in 2014 will rise to US$5.7 billion by 2023.
Internally it cooperates with other department like drug development, manufacturing, marketing and clinical research. Externally, it is the key interface between the company and the regulatory authorities. Industrialized regulatory affairs are to drive compliance, speed to market, and cost efficiency.
Regulatory Affairs is a profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, cosmetics.
Regulatory Affairs importance is to provide the strategic regulatory framework for the submission, to advise on procedures and formats, to collect, evaluate and compile the scientific data and information on the product and to share knowledge with the Pharma Industry Professionals, Professors and Students. Both Pharma companies and Bulk drug industries can be involved.
The regulation of medical products has been expanding since early 20th century. Regulatory agencies are being established in an ever increasing number of countries across the globe. Those that have established are reorganizing their systems and attempting to harmonize with organizations of other countries. The pharmaceutical, biotechnology and medical devices are among the most highly regulated industries in the world.
Regulatory Affairs Professionals Society (RAPS) Professional Development Framework (PD Framework) for the healthcare product regulatory affairs (RA) profession. The PD Framework offers a model for describing the basic body of knowledge and relevant skills of the RA profession across product lines, geographic locations and employer types at four major career stages. The framework is the result of years of research and development carried out by RAPS with the involvement of members worldwide. The studies’ results provide valuable insights into the nature of the profession. The framework defines the profession by professional/career levels, domains that reflect steps in the healthcare product lifecycle, the responsibilities and tasks of the RA professional at each step and the associated core knowledge and skills required of the professional.