Pharmaceuticals can be defined as "chemical substances used in the treatment, cure, prevention or diagnosis of disease or used to otherwise enhance physical or mental well-being" (Ref: Dictionary.com). They may be prescribed for a limited duration or on a regular basis for chronic disorders and can be for human or veterinary use.
January 01, 2017: DCAT Value Chain Insights post states that “total spending on medicines is forecast to reach $1.5 trillion by 2021, up 33% from 2016 levels”. It is predicted that most growth will be in the areas of oncology, autoimmune and diabetes treatments. The US will continue to be a key driver for growth as it is forecasted to account for 53% of growth over the next five years with China being second by contributing 12% of growth.
The regulation of medicines really came into being in the 1950s and 1960s when Thalidomide, taken in the early stages of pregnancy to relieve morning sickness, caused unpredicted serious birth defects. To prevent this from happening again, in 1963 the Committee on Safety of Drugs was set up. Under the terms of the Medicines Act of 1968, this committee was renamed the Committee on Safety of Medicines and later, the Commission on Human Medicines. This Act requires that medicines must be licensed before they can be sold in the UK. Licences for medicines are only granted when a product meets high standards of safety and quality and works for the purpose intended. Now it is the Medicines and Healthcare products Regulatory Agency (MHRA) which regulates medicines, medical devices and blood components for transfusion in the UK.
The US Food and Drug Administration (FDA) can trace its origins back to the appointment of Lewis Caleb Beck in the Patent Office around 1848 to carry out chemical analyses of agricultural products, a function that the newly created Department of Agriculture inherited in 1862. Then in 1930 the department was given the name “Food and Drug Administration” which was based on the 1906 Pure Food and Drugs Act. Since then the FDA and its responsibilities have gone through immense change to keep up with the rapid developments which have occurred during the past century. To this day, these changes continue.
With advances in technology, new challenges are faced by Health Authorities. Therefore, the rules and regulations surrounding pharmaceuticals also have to continually change to keep up and invariably regulations must increase.
Please contact us with your specific regulatory compliance requirements. We look forward to working with you.