According to the eSubmission Roadmap, from July 1^st 2019, the use of the Common European Submission Portal (CESP) has become mandatory also for AIFA.

This system is applicable only to mutual recognition and decentralized procedure (MRP/DCP) submissions, for the moment, while for the national procedures, companies should follow the same rules.

However, in order to ensure an appropriate implementation of the CESP program, despite the submission via CESP, AIFA recommends maintaining the same submission modalities (following the dispositions of 20^th December 2018): for new MAA/line extension submitted through national, mutual recognition, repeat use and decentralized procedures, the eCTD sequence should still be provided to AIFA in a CD-ROM by courier with the relevant cover letter and eAF (original signed paper copy or digital signed electronic copy).

For variation applications and renewals, the upload on the AIFA Front END system is still required, together with the cover letter and eAF (original signed paper copy or digital signed electronic copy). In this case, the submission of the CD-ROM is required only when the size of the documentation does not allow the upload on the system.

As for the Active Substance Master File (ASMF), the dossier should be submitted in eCTD format in a CD-ROM by courier, together with a submission letter and signed letter of access (original signed paper copy or digital signed electronic copy).

RPN has created its own CESP account and is able to support companies with the submission through the portal.

Due to the severe impact of COVID-19 pandemic, the European Medicines Regulatory Network has agreed to extend the deadline to complete and submit the outcome of step 1, risk evaluation of all human medicines containing chemically synthesized active substances for the presence of Nitrosamines, which was foreseen for 26 March 2020, according to the “Information on nitrosamines for marketing authorization holders”. The deadline has been shifted to 1 October 2020 and marketing authorization holders are encouraged to provide the outcomes before this date, following the same procedure.

Covid-19 pandemic has led to different restrictions that may also have an impact on some on-site Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) inspections.

The Q&A recently issued by the European Commission, EMA and the European medicines regulatory network has articulated appropriate measures to address such restrictions and minimize risks of shortages while ensuring that the high standards of quality, safety and efficacy of medicines made available to patients in the EU are maintained.

The measures put in place in order to guarantee the continuous respect of GMP and GDP requirements are the extension of the validity until the end of 2021 for:

• GMP certificates and authorizations to the manufacture and importation of medicinal products (using different approaches for sites located in the EEA and outside the EEA)
• GDP certificates and authorizations to wholesalers and distributors

Some adaptations (always in respect of the GMP requirements) have been introduced also to the role of the Qualified Person (QP), such as:

• remote batch certification
• remote audits of the active substance manufacturer
• remote batch release of investigational medicinal products imported from third countries.

Regulatory Pharma Net team is available to fully support companies for any query.

Due to the current COVID-19 pandemic, EMA has taken lots of initiatives (EMA/213341/2020) to accelerate the development support and evaluation procedures for COVID-19 treatments and vaccines.

These measures concern the following aspects:

• Rapid Scientific Advice, which leads developers to a prompt guidance on the best methods and study design to generate adequate data on medicine and vaccines.
• Rapid agreement of Paediatric Investigation Plan (PIP), which offers to establish a rapid and flexible approach for a PIP, deferral or waiver for treatments and vaccines for COVID-19.
• Rolling Review, which is an ad hoc procedure used in an emergency context to allow EMA to continuously assess the data for an upcoming highly promising application as they become available.
• Marketing Authorisation to encourage applicants to contact EMA early in the product development to discuss scientific and regulatory aspects of their planned application for the prevention or treatment of COVID-19.
• Extension of indication and of marketing authorisation to encourage Marketing Authorisation Holders (MAH) to share early information about their planned development for already authorised products for the treatment or prevention of COVID-19.
• Compassionate use programme in order to facilitate the availability to patients of new COVID-19 treatment or prevention options that are under development.

Regulatory Pharma Net team is available to support companies through all these procedures.

The European Medicines Agency (EMA) and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) signed a confidentiality agreement, which came into effect on 26 March 2021, with the Brazilian Authority Agência Nacional de Vigilância Sanitária (ANVISA).

This represents a first step towards a mutual agreement between EU and Brasil, which both recognized the necessity of a regulatory harmonization to improve the human and animal health.

The Authorities are indeed exchanging information concerning the safety, quality and efficacy of both human and veterinary medicines (already authorised or under evaluation) as well as information on inspections, regulatory guidance and legislation.

Regulatory Pharma Net is available to provide additional insight and updates on the agreement status.

The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) has provided Marketing Authorization Holders (MAH) with the criteria used to assign different MA numbers during the initial marketing authorization process or when requesting new pack sizes in addition or in replacement of those already authorized. To facilitate future submissions, an explanatory table has been prepared that summarizes the most common cases.

This table includes information on:

• The different cases identified;
• When different MA numbers are assigned in the context of the procedure for the initial marketing authorization or variation application to add new pack sizes;
• When different MA numbers are assigned within the procedure for the variation application to replace packaging;
• Clarifications or particular cases to consider as exceptions.

Regulatory Pharma Net provides full regulatory assistance during the whole product lifecycle and is ready to support companies on all regulatory needs and to guide them through any new AIFA requirement/procedure.