Summary of the Italian Medicines Agency's (AIFA) press releases and measures on the COVID-19 emergency as of 17 March 2020

• AIFA and the National Institute for the study and treatment of cancer in Naples launched a study for the use of Tocilizumab in COVID-19 (17 March 2020)

AIFA announced the authorization of the TOCIVID-19 study which will evaluate the efficacy and safety of tocilizumab in the treatment of pneumonia during COVID-19. The study is promoted by the National Institute for the study and treatment of cancer in Naples with the University of Modena and Reggio Emilia and the IRCCS of Reggio Emilia, and with the Technical Scientific Committee of AIFA. All clinical centres that request it will participate in the study and will be managed by the promoter's web platform (the Pascale Institute of Naples). Details of the study are on AIFA’s website.

• Actions taken to encourage research and access to new drugs for the treatment of COVID-19 (17 March 2020)

AIFA advised that it had taken some actions to encourage early access to therapies and facilitate the conduct of clinical trials on the efficacy and safety of the new therapies used for the treatment of COVID-19. In particular:

1. use of drugs in special circumstances: AIFA’s Technical Scientific Committee expressed a favourable opinion on the off label use of the some drugs for the treatment of SARS-CoV-2 infection and on the inclusion in the list of drugs that can be supplied pursuant to law 648/96.
2. clinical trials and access to new drugs: AIFA informed that there are clinical trials already authorised and other experimental protocols are in course of evaluation.

• Extraordinary ways of submitting certificates of pharmaceutical products and parallel import applications (17 March 2020)

AIFA gave instructions on how to submit applications (i) for the certificates of pharmaceutical products (CPP) and (ii) for the new authorisation for parallel import (API), changes and renewals of parallel imported medicinal products.

• AIFA clarifications on COVID-19 and use of ACE-Inhibitors and Sartans (17 March 2020)

AIFA issued some clarifications and recommendations on the use of ACE inhibitors and sartans.

• Suspension of the update of the Transparency List (16 March 2020)

AIFA has communicated that the updating of the Transparency List on its portal is temporarily suspended until 3 April, 2020.

• Two new clinical trials to test remdesivir (12 March 2020)

AIFA and Gilead have announced that Italy will participate in the two studies promoted by Gilead Sciences to evaluate the efficacy and safety of the remdesivir in hospitalized adults diagnosed with COVID-19. The studies will be conducted at the Sacco Hospital in Milan, the Polyclinic of Pavia, the Hospital of Padua, the University Hospital of Parma and the National Institute of Infectious Diseases Lazzaro Spallanzani. Remdesivir has not yet been approved by regulatory authorities for therapeutic use and is provided for compassionate use only.

• Extension of the compilation of AIFA’s monitoring registers (12 March 2020)

AIFA has communicated that in case of difficulty due to the COVID-19 emergency, the mandatory entry of data relating to treatments with medicinal products subject to monitoring via the web-based AIFA register can be postponed to a maximum of 90 days from 12 March 2020. This measure is valid only in case of patients already undergoing treatment, registered on AIFA platform, and are in any case excluded the start of new treatments and the registers of innovative drugs (pursuant to art.1, paragraph 404, Law 232/2016 and available at the web address: https://www.aifa.gov.it/farmaci-innovativi), also already in place.

• The Coronavirus Crisis Unit for the COVID-19 emergency has been set up (12 March 2020)

The Coronavirus Crisis Unit has been set up and, in collaboration with the Scientific Technical Committee (CTS), it is involved in the COVID-19 emergency for the following:

1. "Off label" drugs. In consideration of the fact that in the emergency hospitals refer to protocols providing for the off-label use of medicinal products on the market in Italy, AIFA is preparing the approval of those already identified, which will be subject to the CTS’s evaluation.
2. Research and development/access to experimental drugs. In consideration of the results of some pharmaceutical products being tested, AIFA will proceed in the next few hours to the relevant discussion in CTS regarding clinical studies and compassionate uses for drugs based on remdevisir and tocilizumab.
3. National management guideline. Participation in the development of the national management guideline, relating to the COVID-19 cases, in collaboration with the Civil Defence service (CTS) and the National Institute of Infectious Diseases Lazzaro Spallanzani.
4. Counter shortages of drugs at hospital level. AIFA is in contact with MA holders and importers regarding the regularity of supplies of drugs used at hospital level during an emergency, and proceeds to facilitate the import of critical products.

• Supplementary documentation relating to new MA/extension of MA, changes and renewals of MAs until the end of the restrictions for the COVID-19 emergency (12 March 2020)

 AIFA has advised that the Area Autorizzazioni medicinali will deem acceptable:

1. the submission of applications/notifications of variation and renewal of MAs at the time of uploading to the respective portals, pending receipt of this press release;
2. the receipt via CESP of the applications for MA/line extension of national Mutual Recognition and Decentralised procedures, pending receipt of this press release.

The foregoing also applies to supplementary documentation.

• Clinical trial management in Italy during the COVID-19 emergency (12 March 2020)

AIFA provides detailed indications regarding the management of clinical studies and substantial amendments during the COVID-19 emergency period in Italy, valid until further notice.

• Suspension of Conferences and Congresses (11 March 2020)

AIFA has communicated that all the events already evaluated scheduled for a date in the period March 8 - April 3 are automatically suspended. AIFA will postpone all events ex officio to a fictitious date (the same date in 100 years), in this way users will be able to reschedule the events with due caution.

For events whose dates are after the period 8 March 8 - 3 April, all postponements are currently suspended.

• Transitional measures relating to the extension of AIFA therapeutic plans regarding the containment and management of the emergency from COVID-19 (11 March 2020)

AIFA has communicated that, until the end of the emergency, the validity of web-based or paper-based therapeutic plans (PT) already signed by specialist doctors and which expire in the months of March and April will be extended by 90 days upon expiration date. At the end of the aforementioned extension period, in the absence of new communications, the renewal of the PTs must take place in the usual manner.

In case the patient presents a worsening of the disease or an intolerance to treatment, the extension of validity cannot be automatic, but the reference specialist must be contacted in a way that will be defined by the individual Regions.

• Derogation from the timing scheduled for the implementation of the Procedure for the Modification of Promotional Material (10 March 2020)

The Ufficio Informazione Scientifica has communicated that it deems it appropriate to derogate, for the duration of the emergency, from the timing set out in the Manual User Role Company Ver. 2.1.1 of 07 February 2020 in paragraph “2.4.4 Practical acquisition of MP modification".

From 10 March 2020 and until the end of the emergency, the instructions on page 41 of the Manual regarding the implementation date ("must be later than the tenth day following the presentation of the modification file on the Front-End") ceases to be valid and the modifications in compliance with the indications provided in paragraph 2.4.4 and related, for example, to the methods of disclosure of promotional material, may be implemented immediately.

• EMA communication on the potential impact of the new COVID-19 on the supply of medicinal products in the EU (10 March 2020)

The EMA and the network of national regulatory agencies are closely monitoring the potential impact of the new Covid-19 epidemic on pharmaceutical supply chains in the European Union (EU).

An executive group has been established chaired by the European Commission whose mandate is to provide strategic leadership for urgent and coordinated action with the National Agencies and the pharmaceutical industries within the EU in the event in which a crisis caused by relevant events, such as the COVID-19 epidemic, are likely to have an impact on the supply of medicinal products for human and veterinary use.

• Suspension of the Administrative Acts Notification Service (10 March 2020)

 AIFA has communicated that the notification activities of the Agency are temporarily suspended until 3 April 2020.