(Total Views: 348)
Posted On: 04/17/2019 4:15:07 PM
Post# of 72446
So we don't need the minutes from the CHMP meeting because IPIX won't be part of the minutes anyway?
SO IPIX got their advice and are ready to rock and roll?
The European Medicines Agency (EMA) can give scientific advice and protocol assistance to medicine developers. For human medicines, scientific advice and protocol assistance are given by the Committee for Medicinal Products for Human Use (CHMP) on the recommendation of the Scientific Advice Working Party (SAWP).
Scientific advice is when the Agency gives advice to a developer on the appropriate tests and studies in the development of a medicine. This is designed to facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefit of patients.
Medicine developers can request scientific advice from the EMA at any stage of development of a medicine, whether the medicine is eligible for the centralised authorisation procedure or not.
Scientific advice helps to ensure that developers perform the appropriate tests and studies, so that no major objections regarding the design of the tests are likely to be raised during evaluation of the marketing-authorisation application. Such major objections can significantly delay the marketing of a product, and, in certain cases, may result in refusal of the marketing authorisation. Following the Agency's advice increases the probability of a positive outcome.
The Agency gives scientific advice by answering questions posed by medicine developers. The advice is given in the light of the current scientific knowledge, based on the documentation provided by the medicine developer.
Scientific advice is prospective in nature. It focuses on development strategies rather than pre-evaluation of data to support a marketing-authorisation application.
Scientific advice received from the Agency is not legally binding on the Agency or on the medicine developer with regard to any future marketing-authorisation applications for the medicine concerned.
SO IPIX got their advice and are ready to rock and roll?
The European Medicines Agency (EMA) can give scientific advice and protocol assistance to medicine developers. For human medicines, scientific advice and protocol assistance are given by the Committee for Medicinal Products for Human Use (CHMP) on the recommendation of the Scientific Advice Working Party (SAWP).
Scientific advice is when the Agency gives advice to a developer on the appropriate tests and studies in the development of a medicine. This is designed to facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefit of patients.
Medicine developers can request scientific advice from the EMA at any stage of development of a medicine, whether the medicine is eligible for the centralised authorisation procedure or not.
Scientific advice helps to ensure that developers perform the appropriate tests and studies, so that no major objections regarding the design of the tests are likely to be raised during evaluation of the marketing-authorisation application. Such major objections can significantly delay the marketing of a product, and, in certain cases, may result in refusal of the marketing authorisation. Following the Agency's advice increases the probability of a positive outcome.
The Agency gives scientific advice by answering questions posed by medicine developers. The advice is given in the light of the current scientific knowledge, based on the documentation provided by the medicine developer.
Scientific advice is prospective in nature. It focuses on development strategies rather than pre-evaluation of data to support a marketing-authorisation application.
Scientific advice received from the Agency is not legally binding on the Agency or on the medicine developer with regard to any future marketing-authorisation applications for the medicine concerned.
(1)
(0)
