"Medicine developers who wish to conduct clinical trials in the EU need to submit applications to healthcare competent authorities of the countries where they want to conduct the trials. EMA does not have a role in the authorisation of clinical trials in the EU; this is the responsibility of the national competent authorities"
"Examples of questions addressed during scientific advice Are the patients to be included in a study sufficiently representative of the population for whom the medicine is intended? Are the planned measures to assess the benefits of a medicine valid and relevant? Is the proposed plan to analyse results appropriate? Does the study last long enough and include enough patients to provide the necessary data for the benefit-risk assessment? Is the medicine being compared with an appropriate alternative? Are the plans to follow the long-term safety of the product appropriately designed?"
"For each scientific advice procedure (or ‘protocol assistance’ procedure for orphan medicines) validated, two members of the SAWP who have sound expertise to address the scientific questions are appointed as coordinators. Each coordinator forms an assessment team calling on assessors from their national agency. Each team prepares a report addressing the scientific questions; they draft a list of issues for discussion with all the other members of the SAWP and may ask the applicant for any additional documents or clarifications"
"The data submitted by medicine developers in their application for marketing authorisation must comply with EU legislation. They must include a range of information, including on the way the medicine is manufactured, its effects in laboratory studies, benefits and side effects observed in patients, and how risks will be managed, as well as the proposed information to be provided to patients and doctors"
"Information about any possible (known or potential) safety concerns with the medicine, the way risks will be managed and monitored once the medicine is authorised and what information is intended to be gathered from follow-up studies after authorisation is described in detail in a document called the ‘risk management plan’ (RMP). The RMP is evaluated by EMA’s safety committee, PRAC, to ensure its suitability."
"Studies that support the marketing authorisation of a medicine have to comply with strict rules and are conducted in a regulated setting. International standards, called good clinical practice, apply to the study design, recording and reporting to ensure that studies are scientifically sound and conducted in an ethical manner. The type of evidence needed to determine the benefits and risks of a medicine are defined by EU law and must be adhered to by medicine developers. Inspections can be requested by EMA to verify compliance with these standards. EMA supports the conduct of high-quality studies through initiatives such as Enpr-EMA and ENCePP, which bring together expertise from independent academic centres across Europe. Thanks to these initiatives additional sources of evidence can complement the evidence provided by medicine developers, in particular in the context of the continuous safety monitoring of a medicine after its authorisation."
"All medicines have benefits as well as risks. When assessing the evidence gathered on a medicine, EMA determines whether the benefits of the medicine outweigh its risks in the group of patients for whom the medicine is intended. In addition, since not everything is known about a medicine’s safety at the time of its initial authorisation, the way risks will be minimised, managed and monitored once the medicine is more widely used is also an integral part of the assessment and is agreed at the time of authorisation. While the authorisation of a medicine is based on an overall positive balance between the benefits and risks at population level, each patient is different and before a medicine is used, doctors and their patient should judge whether this is the right treatment option for them based on the information available on the medicine and on the patient’s specific situation."
"EMA’s Committee for Medicinal Products for Human Use (CHMP) assesses applications submitted by medicine developers and recommends whether or not a medicine should be granted marketing authorisation. The committee is composed of one member and an alternate from each EU Member State, as well as from Iceland and Norway. It also has up to five EU experts in relevant fields such as statistics and quality of medicines, who are nominated by the European Commission"
"While the majority of new, innovative medicines are evaluated by EMA and authorised by the European Commission in order to be marketed in the EU, most generic medicines and medicines available without a prescription are assessed and authorised at national level in the EU. In addition, many older medicines available today were authorised at national level because they were marketed before EMA was created. Most Member States have registers of nationally authorised medicines."
"Once a medicine has been authorised for use in the EU, EMA and the EU Member States constantly monitor its safety and take action if new information indicates that the medicine is no longer as safe and effective as previously thought. The safety monitoring of medicines involves a number of routine activities ranging from: assessing the way risks associated with a medicine will be managed and monitored once it is authorised; continuously monitoring suspected side effects reported by patients and healthcare professionals identified in new clinical studies or reported in scientific publications; regularly assessing reports submitted by the company holding the marketing authorisation on the benefit-risk balance of a medicine in real life; and assessing the design and results of post-authorisation safety studies which were required at the time of authorisation."
I could quoute a hundred more.
Yes, companies do their studies on medicines. They are its developers. But in the EU, those studies are CHECKED a hundred different times by an enourmous amount of different organizations, both national and supranational,
That's why there are medicines in the USA that are completely forbidden in the EU.
And that's the last message I'm sending.
