European Medicines Agency (EMA)
The accreditation gives you more confidence and security about the products and services you get, also has a parameter to evaluate the quality of the product and / or service and a basis to demand on quality and safeguard their health and safety.
Determination of the degree of compliance with Mexican Official Standards and/or Mexican standards, international standards or other specifications. It includes, among others, sampling, testing, calibration, certification and verification procedures.
Accreditation bodies are responsible for assessing that conformity assessment bodies comply with the requirements established in the applicable standards in order to obtain accreditation.
Accreditation provides confidence to users (businessmen, authorities, producers, consumers) since accreditation ensures that accredited conformity assessment bodies carry out their activities in compliance with the applicable regulations, issuing reliable results reports, certificates and opinions.
What is ema
Berlin (dpa) – The German government on Sunday removed 13 African countries from the list of high-risk areas for coronavirus. Among them are states where the omicron variant of the virus first spread in November, including South Africa and Namibia.
Berlin (dpa) – The German government wants to prepare Germany organizationally for a rapid increase in coronavirus infections, as hundreds of thousands of people are expected to be infected every day. Experts hope that this “omicron wall” will be able to prevent the spread of coronaviruses.
Mainz (dpa) – The Mainz-based pharmaceutical company Biontech and its U.S. partner Pfizer have started production of a coronavirus vaccine adapted to the omicron variant for subsequent commercial use. This was announced by Biontech CEO Ugur Sahin at a health conference of the U.S. bank J.P. Morgan. He said a clinical trial of the vaccine would begin in late January. “We expect to be ready to supply the market in March, once we get the approvals from the authorities.”
List of EMA signatories
Following positive assessments by the European Medicines Agency (EMA) on safety, quality and efficacy, the Commission has so far granted conditional marketing authorization to four vaccines developed by:
The Commission is conducting intensive negotiations with the aim of building up a diversified portfolio of vaccines for EU citizens at fair prices. Contracts have been signed with AstraZeneca (400 million doses), Sanofi-GSK (300 million doses), Johnson & Johnson (400 million doses), BioNTech-Pfizer (2.4 billion doses), CureVac (405 million doses), Moderna (460 million doses), Novavax (200 million) and Valneva (60 million).
The Commission thus guarantees a portfolio of more than 4.2 billion doses. It was important for the Commission from the outset to build up a diversified portfolio of vaccines based on different technologies in order to increase the likelihood that one or more of the experimental vaccines would be approved by the EMA.
The companies “managed to make the technological transfer in record time and the production yields are high, but they are not enough to supply the population to which the vaccine will reach”, pointed out Lamas.
On August 31, the Council of Ministers gave the green light to the early acquisition of the part assigned to our country in the distribution of the 20 million doses committed to the European Union. Deliveries are scheduled for the end of 2021 and the beginning of 2022.