Efficacy . Situation that has exponentially accelerated the arrival of the covid-19 vaccine. Thus, at european level, the european medicines agency (ema) had to assess the situation and agree on a series of measures to facilitate the management of authorizations and modifications of medicines for human use considered essential during this pandemic period. In this sense, a series of regulatory flexibilities have been applied to the pharmaceutical industry to speed up the control of the pandemic. These measures are being applied guaranteeing the quality , safety and efficacy of the medicines marketed.
Regulatory flexibilities applied to the pharmaceutical industry during the pandemic within the flexibilities carried out by the different regulatory entities, it is worth highlighting some in the european framework: issuance of electronic certificates for medicines . Quality variations and labeling and packaging requirements. Use of sites responsible for e commerce photo editing quality control that are not specifically mentioned in the authorization. Suspension of audits and investigations of providers of "minor" events in the case of the medicines and healthcare products regulatory agency of the united kingdom. With all this, we have managed to ensure that the development phases of the vaccines against covid-19 are scrupulously fulfilled with quality assurance , although faster.
What measures were adopted to facilitate the management of drug authorizations? During the covid-19 crisis, a series of measures had to be applied to facilitate the management of authorizations for medicines for human use considered essential. Thus, last year, the ema published a guide “questions and answers on regulatory expectations for medicines for human use during the covid-19 pandemic” . This guide guides holders of marketing authorizations for medicines on the adaptations in the regulatory framework regarding the management of procedures in the context of the covid-19 crisis. The purpose is to facilitate, simplify and