What is a stringent regulatory authority?
A stringent regulatory authority (SRA) is a national drug regulation authority which is considered by the World Health Organization (WHO) to apply stringent standards for quality, safety, and efficacy in its process of regulatory review of drugs and vaccines for marketing authorization.
What is the meaning of regulatory authority?
A regulatory authority is an autonomous enforcing body created by the government to oversee and enforce regulations regarding occupational health and safety. The role of the regulatory authority is to establish and strengthen safety standards and ensure consistent compliance with them.
What is the regulatory system and why is it important?
Essentially, the regulatory system is an important piece of the public health system. By providing manufacturers and producers with unbiased information, guaranteeing the use of best practices, and inspecting producers and manufacturers, the regulatory authority protects the safety of food and medical products.
What is the regulatory system?
Regulatory System means the body of legal requirements for Good Manufacturing Practices, inspections, and enforcements that ensure public health protection and legal authority to assure adherence to these requirements.
What does the ICH do?
The ICH facilitates international electronic communication through the provision of Electronic Standards for the Transfer of Regulatory Information (ESTRI), giving the Electronic Common Technical Document (eCTD), allowing for the electronic submission of the Common Technical Document from applicant to regulator.
What is an example of a regulatory authority?
Regulatory Authority means any national (e.g., the FDA), supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity involved in the granting of Regulatory Approval in any country in the Territory.
What are the responsibilities of regulatory authorities?
Regulatory Authorities are responsible for: granting all approvals, including for providers, services and certified supervisors. assessing and rating services. monitoring and enforcing compliance.
What are the roles and responsibilities of regulatory bodies?
The role of the regulatory body is to establish and strengthen standards and ensure consistent compliance with them. Various regulatory bodies oversee different sectors of the economy and public life, including transportation, education, and the sale of food and drugs.
What are regulatory issues?
Regulatory Issue means any matter involving interaction with a Regulatory Authority or compliance with regulatory requirements.
What is an example of regulatory?
Common examples of regulation include limits on environmental pollution , laws against child labor or other employment regulations, minimum wages laws, regulations requiring truthful labelling of the ingredients in food and drugs, and food and drug safety regulations establishing minimum standards of testing and …
What ICH means?
Ich, a German pronoun meaning I, also a Middle English form of I.
What is the definition of ICH?
Medical Definition of ich : a severe dermatitis of freshwater fish caused by a protozoan of the genus Ichthyophthirius (I. multifiliis) and especially destructive in aquariums and hatcheries. — called also ichthyophthiriasis, ichthyophthirius.
What is the role of ICH?
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together the medicines regulatory authorities and pharmaceutical industry around the world.
What is a regulatory authority in Australia?
Regulatory authorities administer the National Quality Framework (NQF) in each state and territory, usually as part of that state or territory’s education department or agency.
What is the NSW regulatory authority for children’s services?
The NSW Department of Education is the Regulatory Authority in NSW responsible for regulating early childhood education and care services in NSW.
What is the regulatory authority main role when performing inspections?
Regulatory inspections are important to evaluate the integrity of the data submitted to health authorities (HAs), protect patient safety, and assess adequacy of site/sponsor quality systems to achieve the same. Inspections generally occur after submission of data for marketing approval of an investigational drug.
What is a regulatory authority Australia?
What’s another word for regulatory?
What is another word for regulatory?
| supervisory | administrative |
|---|---|
| monitoring | governing |
| regulative | managing |
| executive | ruling |
| official | directorial |
What does SRA stand for?
What does SRA in reading stand for? Science Research Associates Science Research Associates(SRA) was a Chicago-based publisher of educational materials and schoolroom reading comprehension products. The company was acquired by McGraw-Hill Education in the early 2000s.
What are the different types of regulatory authorities?
Authorised Conveyancing Practitioners Board
What does Regulatory Authority mean?
What Does Regulatory Authority Mean? A regulatory authority is an autonomous enforcing body created by the government to oversee and enforce regulations regarding occupational health and safety. The role of the regulatory authority is to establish and strengthen safety standards and ensure consistent compliance with them.
What is the Prudential Regulatory Authority?
What is the Prudential Regulation Authority (PRA)? The Prudential Regulation Authority (PRA) is one of two key regulatory bodies presiding over the financial services industry in the UK. It is responsible for the regulation of more than 1,500 banks, credit unions, building societies, insurance companies and investment firms.