Italian Regulatory Affairs News

Transcription

1 Italian Regulatory Affairs News th July, 2018 Human Medicines Veterinary Medicines Homeopathic Products Medical Devices Diagnostics Food Supplements PMC (Medical Surgical Aids) Biocides Plant Protection Products Cosmetics

2 Di Renzo Regulatory Affairs Viale Manzoni, Roma Tel. 06 / Fax. 06 / newsletter@direnzo.biz Italian Regulatory Affairs News N th July, 2018 WEEKLY MAGAZINE Editor in Chief: Sante Di Renzo Subeditor: Maria Pia Felici Layout: Maurizio Isopo

3 Italian Regulatory Affairs News 3 Italian Regulatory Updates AIFA further clarifications on stock disposal The Italian Medicine Agency has published further clarifications regarding the Decree no. 821 of 24 May 2018 updating the provisions on medicinal products stock disposal. In particular, the Agency authorises the sell-off of products already on the market undergoing the changes described under article 1, comma 2 of the decree provided that pharmacists deliver the updated information leaflet to users. For changes other than those described under article 1, comma 2, the stock disposal is authorised with no need of delivering the updated PIL. For products approved by Centralised Procedure, the MA Holder shall provide pharmacists with the updated PIL in paper or electronic format within 30 days from the date of publication of the European Commission decision for major variations, or from the date of the EMA positive opinion or closing sequence after the CHMP opinion for minor variations. After 6 months from these terms, the new batches, including those manufactured before this period and not released, must be packaged and released with the updated PIL and/or labelling. Finally, the Italian Medicine Agency has updated the forms for the publication of variations falling into the application of the AIFA Decree on silent assent procedure in the Italian Official Gazette. These two forms can be downloaded directly from the Agency website and regards comma 2 and of article 1 of the decree, respectively. The obligation for the MA holders to use these forms for the in the Gazette of changes affecting the Patient Information Leaflet regulated by these articles entered into force on 11 July.

4 Italian Regulatory Affairs News 4 DDLs for levetiracetam, atezolizumab and pembrolizumab The Italian Medicine Agency has published 3 Dear Doctor Letters: The first regards the active substance levetiracetam, indicated for the treatment of epilepsy. The Agency stressed that the new assessment of the data available for pregnant women did not indicate an increased risk of malformations, however the data are not sufficient to rule out a teratogenic risk and the treatment is to be re-assessed in case a pregnancy is being planned. The other two DDLs regard instead the active substances atezolizumab and pembrolizumab, whose indication for the treatment of urothelial cancer is limited to specific conditions following data on the patients survival. New e-address for the clinical trial monitoring The Italian Medicine Agency has changed the address where sponsors of interventional clinical trials or delegated CROs shall submit the annual DSURs. The new address dsur@aifa.gov.it is operational as of 1 st July and replaces the previous ones (DSUR_ITA@aifa.malcert.it and dsur@pec.aifa.gov.it). DSURs transmission through other channels, such as faxes, CD ROMs or other addresses will not be valid.

5 Italian Regulatory Affairs News 5 Drug precursor list updated The Italian Ministry of Health has informed on the update of the list of classified list with the inclusion of drug precursors provided for by the delegated Regulation of the Commission 2018/729 of 26 February 2018, entered into force on 7 July. The new substances included in category 1 are N-phenethyl-4-piperidinone (NPP) and 4-anilino-N-phenethylpiperidine (ANPP), chemical precursors used for the synthesis of phentanyl and several phentanyl analogues. Storage, manufacturing, production, transformation, marketing, distribution, exportation, importation or intermediation of these precursors require the issue of a three-year licence by the Ministry of Health and are regulated both for community transactions and for transactions in third countries. Pharmacies are exempted from this obligation. Holders of this licence are also bound to send annual reports (within 15 February) on the quantities of classified substances under category 1 that were manufactured, purchased, supplied or used in the previous year to the Ministry of Health.

6 Italian Regulatory Affairs News 6 European Regulatory Updates EMA informs on valsartan Following the detection of an unexpected impurity, the European Medicines Agency (EMA) is reviewing medicines containing valsartan supplied by the Chinese manufacturing site Zhejiang Huahai Pharmaceuticals. The impurity (N-nitrosodimethylamine, NDMA) is classified as a probable human carcinogen and its presence in the active substance would be due to changes in the way the active substance was manufactured. The review, carried out by EMA s Committee for Medicinal Products for Human Use (CHMP), will investigate the levels of NDMA, its possible impact on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company. As a precaution the review will also consider other valsartan medicines. In the meantime, national authorities of Member States are recalling medicines containing valsartan supplied by the Chinese company. France intervenes on administrative delays In the frame of a series of measures aimed at attracting to France investors on pharmaceuticals and health, the French government is planning interventions to reduce the time for trial authorisations and price fixing. The Government has underlined the trend of French health to concentrate on known drugs against the propensity to innovation of other European countries. For this, in order to attract research on biotechnologies and gene therapies, France intends to reduce the delays in the market access, reducing the total time from clinical trials to marketing to 5 months. Other measures includes facilitated access to health data by companies, the creation of an excellence pole for research and production in the biotechnologies and the set-up of the relative therapeutic value replacing the actual evaluation mechanism for health products.

7 Italian Regulatory Affairs News 7 The European Committees Committee for Medicinal Products for Human Use (CHMP) Last meeting: June 2018 Next meeting: July 2018 The Committee for Advanced Therapies (CAT) Last meeting: June 2018 Next meeting: July 2018 Paediatric Committee (PDCO) Last meeting: June 2018 Next meeting: July 2018 The Committee for Orphan Medicinal Products (COMP) Last meeting: June 2018 Next meeting: July 2018 The Committee for Risk Assessment in Pharmacovigilance (PRAC) Last meeting: 9-12 July 2018 Next meeting: 3-6 September 2018 Committee for herbal Medicines (HMPC) Last meeting: 4-5 June 2018 Next meeting: July 2018 Committee for Medicinal Products for Veterinary Use (CVMP) Last meeting: June 2018 Next meeting: July 2018 Committee on Biocides (BPC) Last meeting: June 2018 Next meeting: October 2018 The Italian Commissions Open-AIFA: 19 September 2018 AIFA Board of Directors Last meeting: 18 June 2018 Next meeting: 27 July 2018 Technical Scientific Advisory Commission Last meeting: July 2018 Next meeting: The date of the next meeting is not available. The Committee for prices and reimbursement Last meeting: June 2018 Next meeting: July 2018 The Technical Health Committee - Advertisement Last meeting: 12 July 2018 Next meeting: 25 July 2018 Veterinary Commission Last meeting: July 2018 Next meeting: September 2018

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