What is the purpose of regulating drugs?
The harm has come from drug products containing toxic impurities, from drugs with unrecognized severe adverse reactions, from adulterated drug products, and from fake or counterfeit drugs. Because of these issues, effective drug regulation is required to ensure the safety and efficacy of drugs for the general public.
What are the key responsibilities of the drug regulatory authorities?
Health Products Regulatory Authority (HPRA) Their main duties include issuing licensing to companies to allow manufacturing, monitoring these activities and responding to any issues that might arise. In addition, they also produce quality and safety information as guidance for use of health related products.
What is the purpose of drug laws and regulatory agencies?
The regulatory bodies are responsible for the ensuring that all medicine production complies with the rules and regulations and ethical behavior guidelines outlined by the local and international bodies. The governing body ensures that all staff, including technicians, pharmacists, chemists and labor, are qualified.
What are drug regulatory bodies?
The process of testing, developing and marketing of medicines has to regulated to protect the interests of the public. Major regulatory bodies include the Food & Drug Administration (FDA) in the US and the European Medicines Agency (EMA) in Europe. These bodies have various functions.
How is the regulation of drugs in Russia?
Regulation in Russia. There is just one exception to this requirement; if a molecule has been marketed for more than 20 years in Russia then this obligation can be avoided. The law also set out the regulatory framework for the Essential Drugs List (EDL) and the pricing of drugs included on the EDL.
What does the European Medicines Agency do in Russia?
The European Medicines Agency (EMA) supports the European Commission’s activities in Russia, by contributing to interactions on pharmaceuticals between the European Union (EU) and the regulatory authorities of Russia.
Who is responsible for the regulatory framework in Russia?
The authorities responsible for applying and enforcing the regulatory framework shall be: in relation to drugs and biologicals – the Ministry of Healthcare of the Russian Federation (the “Minzdrav”) and the Federal Service for Surveillance in Healthcare (the “RZN” ); in relation to medical devices – RZN.
When was the Federal Drug Control Service of Russia renamed?
On March 9, 2004, The Russian Federal Drug Control Service was renamed the Federal Service of the Russian Federation for the control of narcotic drugs and psychotropic substances and on July 28, 2004, the Russian Federal Service for Control over Traffic in Narcotic Drugs and Psychotropic Substances was renamed the Russian Federal Service…