Titolari AIC, obbligati al test di leggibilità

I titolari delle autorizzazioni all'immissione in commercio di medicinali per uso umano sono tenuti ad eseguire dei test di leggibilità sui fogli illustrativi contenuti nelle confezioni dei prodotti. La Direttiva Europea 2004/27/CE definisce che il foglietto illustrativo deve  rispecchiare i risultati delle consultazioni con i gruppi per assicurarsi che sia leggibile, chiaro e facile da usare.

Inoltre indica che i risultati delle valutazioni realizzate in cooperazione con gruppi mirati di pazienti devono essere forniti alle autorità competenti. Ma, come è il caso di molte direttive , non ci sono informazioni assolutamente chiare su come si devono essere eseguiti i test di leggibilità.

Le autorità di regolamentazione vogliono assicurarsi che i foglietti illustrativi vengano testati in modo professionale e che i pazienti siano in grado di trovare le informazioni richieste, capirle e agire di conseguenza.

La maggior parte dei fornitori di servizi di test di leggibilità utilizzano il metodo studiato dai ricercatori Sless e Wiseman. Almeno il 90% dei partecipanti al test dovrebbe essere in grado di trovare le informazioni richieste, e di quelle ancora una volta, il 90% dovrebbe capire i dati.

Il triangolo sui fogli illustrativi

L'Unione europea ha introdotto un nuovo modo per identificare i medicinali che necessitano un monitoraggio di particolare attenzione. Questi farmaci hanno un triangolo nero rovesciato nel foglietto illustrativo e la frase “Questo medicinale è soggetto a monitoraggio addizionale"

Tutti i farmaci immessi in commercio sono attentamente monitorati durante il loro ciclo vitale, tuttavia i farmaci con il triangolo nero vengono monitorati più da vicino rispetto ad altri per alcuni motivi come, le poche informazioni disponibili su di essi in confronto con altri farmaci, per esempio perché sono nuovo sul mercato. Ciò non significa che il medicinale sia a rischio.

Potete trovare maggiori informazioni su questo link.

CPhl worldwide – Frankfurt – 22-24 Octubre 2013

Di Renzo Regulatory Affairs participará en la feria CPhl worldwide, que tendrá lugar del 22 al 24 de Octubre 2013 en Frankfurt, stand n. 42J50.

Di Renzo ofrece servicios de consultoría en el ámbito de los dispositivos médicos para asesorar a los fabricantes de dispositivos médicos sobre la exportación de dispositivos con la marca CE fuera de la Unión Europea. Para la comercialización de dispositivos médicos en algunos países extracomunitarios es suficiente presentar un certificado de venta libre expedido por la autoridad competente del país en el que se encuentra la sede del fabricante. Para otros países, como por ejemplo los Estados Unidos, es necesario responder a los requisitos de la FDA. Di Renzo ofrece sus servicios a las empresas interesadas tanto en el mercado europeo como el mundial.

CPhl worldwide 2013

La Di Renzo Regulatory Affairs parteciperà alla fiera CPhl worldwide, che si terrà dal 22 al 24 Ottobre 2013 a Francoforte, stand n. 42J50.

La Di Renzo offre servizi di consulenza nell’ambito dei dispositivi medici per supportare i fabbricanti di dispositivi medici nell’esportazione di dispositivi marcati CE fuori dai paesi appartenenti l’ Unione Europea. Per commercializzare i dispositivi medici in alcuni Paesi extra EU è sufficiente fornire un certificato di libera vendita rilasciato dall’autorità competente del paese in cui ha sede il fabbricante. Per altri paesi, come per esempio gli Stati Uniti, è necessario rispondere ai requisiti dell’ FDA. La Di Renzo offre supporto alle aziende interessate sia al mercato europeo sia mondiale.

CPhl worldwide event in Frankfurt – October 22-24th, 2013

 

Di Renzo Regulatory Affairs will take part to the CPhl worldwide event in Frankfurt this year as well.

This is a very interesting occasion for international companies attending the event and visiting the booths to learn about the potentials of the organization set up by his owner, Sante Di Renzo, in thirty years of activity.

The group currently comprises of almost 60 people, most of whom are graduated in scientific subjects, and deals with regulatory affairs for human and veterinary medicines, medical devices, cosmetics, food supplements, biocides.

It also have an efficient pharmacovigilance unit (made of almost 20 people, including two QPs and two physicians), a devicevigilance unit and a cosmetovigilance unit.

The company’s main office is in Rome, with a branch in Milan and one in London. The opening of other branches in other parts of the world is scheduled, stressing the international vocation of the organization.

All companies interested in meeting us are invited to visit our booth no. 45J50 or to send us an e-mail to make an appointment.

Latex-containing packagings

The Pharmacovigilance Office of the Italian Medicine Agency (AIFA) required all pharmaceutical companies to check that a warning regarding the presence of latex rubber in the primary packaging material or in medical devices supplied with some medicines is duly reported in the PIL of medicinal products.

The warning, provided for by the guideline Excipients in the label and package leaflet of medicinal products for human use, is the only way to protect patients suffering from allergies to latex. Italian hospitals have recently reported cases of latex-related anaphylactic shock and the AIFA pointed out that, although latex is not considered as an excipient, it is often contained in vials’ stoppers or in plungers of pre-filled syringes.

The warning states the following: “The container of this medicinal product contains latex rubber. May cause severe allergic reactions”.

In case such warning is not reported, the Company will have to submit a variation application to the Competent Authority as soon as possible, in any case no more than 30 days from the receipt of this communication, according to Regulation EC no. 1234/2008, in order to include this warning in the PIL.

Red yeast rice: alert from France

The French Agency has launched an alert on food supplements containing red yeast rice, often labelled with claims on control of blood cholesterol. 

The Agency underlined that although containing monacolin K (also known as lovastatin) showing the same chemical characteristics of statins, products containing red yeast rice should not replace the therapies prescribed by the physician against cholesterol. Besides, after some reports of adverse events related to the use of such supplements, they should not be recommended to patients already under pharmaceutical treatment. 

These reports led to a review by ANSES (the French food safety agency) which assessed all the risks due to the consumption of these supplements. For the moment only few cases were reported, but the undesirable effects detected were similar to those listed for statins used in pharmaceutical products, such as increased frequency of muscular pain and increased hepatic enzymes with signs of jaundice. 

Therefore, the Agency has warned patients against the replacement of anti-cholesterol therapies with food supplements containing red yeast rice, especially in case of statin intolerance, since the undesirable effects are the same. Patients already treated with an anti-cholesterol therapy or receiving medicinal products interacting with statins should not take these supplements. Also grapefruit and grapefruit juice consumption should be avoided since this can increase the exposure to lovastatin with consequential overdose risk. 

Finally, patients were reminded that the therapy for hypercholesterolemia should always be accompanied by an appropriate low-fat regime and physical exercise.

Safety of cosmetics phthalates confirmed

Scientists and researchers of the Scientific Committee on Consumers Safety confirmed the safety of the only phthalate used in cosmetics sold in Europe. This is diethyl phthalate (DEP), added in small amounts to bitter the taste of ethylic alcohol when contained in the formulation.

The Committee reacted to the warning launched by the Washington University of St. Louis, according to which phthalates exposure results in premature menopause.

Considering that this is a wide class of chemicals with different characteristics and properties, the Committee confirmed that phthalates with negative characteristics are forbidden in cosmetics and therefore no cosmetic product containing such phthalates is available in the Italian and European market.

Besides, cosmetic products are regulated by strict European and Italian regulations, which guarantee consumers’ safety.

Teeth whiteners

From next October 31st teeth whiteners containing up to 6% of hydrogen peroxide cannot be marketed as medical devices. These products will be in fact considered as cosmetics.

Teeth whiteners containing less than 6% of hydrogen peroxide are still under discussion at European level and for the moment can be kept on the market as medical devices.

Pharmacovigilance: formal EMA investigation against multinational

The European Medicine Agency launched an infringement action against a multinational company for serious violation of the pharmacovigilance obligations on twenty products authorized through CP.

The action follows an inspection carried out by the British regulatory authority (MHRA), which detected serious faults in the company pharmacovigilance procedures.

The infringement action was started based on art. 5 of Regulation EC no. 658/2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004.

EMA will report on the investigation outcome to the European Commission which may impose fines or periodic penalty payments if the violation is confirmed. EMA will proceed with an assessment of the general impact of the violation on public health.

Pharmacovigilance is more and more preponderant among pharmaceutical companies’ activities and requires a remarkable organization and great responsibilities. 

Born out of the increasing need to continuously control the efficacy of medicinal product in their post-marketing phase, its aim is to collect information on medicinal products, as well as on their efficacy and in particular on their adverse reactions.

Di Renzo Regulatory Affairs is able to offer a wide range of pharmacovigilance services in compliance with current European and National regulations and legislations:

• Control of National network of pharmacovigilance for possible adverse reactions related to the products
• Request of follow-up information to the local pharmacovigialnce responsible person
• Preparations of forms
• Transmission of ICRS and information on pharmaceuticals through the Eudravigilance network
• Search and evaluation of literary cases, and of safety and efficacy studies
• Preparation and submission of PSUR to the Competent Authorities
• Local contact and Qualified Person for the Pharmacovigilance

Contact us for any information on our pharmacovigilance services: direnzo@direnzo.it

CPhI Worldwide exhibition

For the first time Di Renzo Regulatory Affairs participated in the CPhI Worldwide exhibition, held from the 9th to the 11th of October, with its own stand.

The event took place in the wide space offered by the prestigious Madrid Fair. It hosted several companies coming from all over the world, dealing with different sectors of the pharmaceutical field: medicinal products or API producers, experts in packaging, labelling or transport, manufacturers of cosmetics, medical devices, different types of machinery or equipment and many others, among which regulatory consultancy companies as Di Renzo Regulatory Affairs.

Such events are well known by those companies intending to work at international level. These exhibitions have become an essential instrument for the acquisition of important business contacts, for the choice of appropriate partners or in order to allow companies to join an always wider and more international sector.
We would like to thank once more those companies which came to visit us.

Raw materials importation

AIFA informed Italian companies about the European Commission communication on the obligation of written confirmation by the competent authority of the country of origin for the importation of pharmacologically active raw materials manufactured in extra-EU countries, starting from July 2nd 2013.

The EC communication informed that MAHs using imported pharmacologically active raw materials or derived from other imported pharmacologically active raw materials are invited to check that the extra-EU manufacturer complies with the requirement of the written confirmation within July 2nd 2013 (by checking for instance that the manufacturer was inspected by the competent national Authority of the manufacturing country or by a regulatory authority which is part of the PIC/S).

Pharmacologically active raw materials can be imported from extra-EU countries without the written confirmation only if originated by countries considered as “equivalent” by the European Commission. At the moment these equivalent countries are only four: Israel, Switzerland, Australia and Singapore.

If the concerned manufacturer is not able to grant a written confirmation, the company should proceed to develop an emergency plan to select new sources of the pharmacologically active raw material and submit the relevant variation application to AIFA.

MAHs are reminded that it is their specific responsibility to grant appropriate and continuous supplies of the medicines in order to satisfy the patients needs, according to art. 81 of Directive 2001/83 as amended, implemented in art. 105, sections 2 and 4, of Legislative Decree 219/06. Therefore, MAHs are bound to avert any risk of shortage due to the lack of a written confirmation starting from July 2nd 2013.

Nano substances: cosmetics guideline

The European association “Cosmetics Europe” published a guideline on the correct implementation of Regulation 1223/2009/EC. The “Nano Guidance Package” is made of 5 documents, edited by special working groups formed by industry experts, in order to support cosmetic companies with the issues of nano materials when present in cosmetics. The association considered a Guidance was necessary due to the lack of more specific information by the Authorities.  The guideline is currently available only in English.

Regulatory Affairs Consultancy

Di Renzo Regulatory Affairs, whose headquarters are in Rome (Via Manzoni 59, tel. 06 77209020 FREE 06 77209020), has also set up a branch in Milan (Via Gustavo Fara 13, tel. 02 67380552 FREE 02 67380552).

Initially, the Milan office was only used for meetings with companies who required our consultancy.
As of November 2012 our Milan office will be operational in all respects, with the constant presence of our staff.
We will be happy to be contacted by and meet with companies who need our services.

The areas of our interest are medicinal products, medical devices, cosmetics, food supplements, biocides and disinfectants.
The flagship of our business is the pharmacovigilance unit, made up of a large and highly specialised staff.

In order to obtain more specific information regarding the nature of our services, please visit www.direnzo.biz

For more information: Sante Di Renzo, direnzo@direnzo.it

Intervista a Antonella Mencarelli

Antonella Mencarelli lavora da molti anni con la Di Renzo Regulatory Affairs, come responsabile per lo sviluppo delle attività. Parla correttamente cinque lingue e attualmente è impegnata nell'organizzazione dell'evento di Madrid del CPHI 2012

Ci affidiamo alla sua competenza per saperne di più del settore dei servizi regolatori.

D - Cosa trova di stimolante nel suo lavoro?

R - La cosa che più mi affascina, del modo in cui è strutturato il mio lavoro qui alla Di Renzo Regulatory Affairs, è il dinamismo che si respira: la voglia di fare, di conoscere, di apportare novità, di sperimentare. Tutte le persone che fanno parte del nostro gruppo lavorano con questo spirito; ognuno concorre al raggiungimento e al mantenimento della qualità e della competenza che gli esperti del settore ci attribuiscono. Sapere che parte della riuscita dell'azienda passa per le mie capacità mi rende davvero motivata. È una sensazione endemica, che si percepisce subito, già dopo il primo giorno di lavoro, perché c'è grande attenzione da parte di tutti per le altrui potenzialità. Non c'è invidia o competizione sleale, ma voglia di fare insieme, di collaborare per qualcosa che non è più solo mio o di un altro, ma nostro.

D - Esattamente, qual è la sua mansione specifica?

R - Di mansioni ne ho davvero tante, ma non sono state fissate su una job description. Mi prendo tutti gli incarichi e le responsabilità che riguardano lo sviluppo, in Italia come all'estero, delle attività regolatorie. Siamo stati abituati a non aspettare che ci dicano cosa dobbiamo fare, bensì a prenderci carico di quello che sappiamo fare e a creare nuove soluzioni laddove le abituali si dimostrano inefficaci. Per far ciò in maniera costruttiva, tra noi e la struttura in cui lavoriamo, deve esserci una sorta di simbiosi, un senso etico del vantaggio comune.

Al momento sto organizzando, in tutti i suoi dettagli, l'evento di Madrid, CPHI 2012
Sono convinta che faremo una bella figura e che avremo modo di farci conoscere meglio anche dalle aziende internazionali.

D - Mi colpisce molto il suo entusiasmo. Sento che lei è davvero contenta di far parte di questo gruppo, è così?

R - Infatti, è proprio così. C'è entusiasmo e anche stima reciproca. Conosco Sante (Sante Di Renzo) da moltissimi anni e quando mi ha detto che al suo gruppo serviva una persona con spiccata capacità di relazionarsi con il prossimo (sono parole sue) sono stata felice di essere la persona giusta al momento giusto. In tutti questi anni abbiamo fatto davvero molti passi avanti. Insieme. Credo che in qualche modo anche io ho contribuito alla crescita dell'azienda e questo mi rende particolarmente orgogliosa. Sento che in questo gruppo io esisto, ci sono, ho un ruolo e sono utile. E ho la precisa sensazione che quasi tutti vivano della mia stessa convinzione.

D - La sua azienda dunque è in crescita. Non ha paura che un'eccessiva espansione possa compromettere quel clima amicale e familistico che vi ha contraddistinto?

R – Ad oggi siamo una cinquantina di persone, e non c'è stata alcuna spersonalizzazione dei rapporti professionali. Forse anche perché Sante ogni tanto, proprio per non stancare mentalmente le persone, chiede di fare proposte e avanzare soluzioni di lavoro alternative. Attribuisce a ciascuno di noi compiti sempre nuovi, stimolanti, che non ci permettono di cadere nella trappola del lavoro ripetitivo. Così siamo invogliati non solo ad affrontare nuovi argomenti, ma anche a sviluppare i rapporti di collaborazione con altre persone del gruppo e ad attivare nuovi rapporti esterni, con aziende e funzionari delle amministrazioni alle quali solitamente ci riferiamo. Devo dire che è un ottimo metodo: una sorta di turn-over interno, così le persone non vanno via e non si assentano per stanchezza o disinteresse.

Fa davvero piacere incontrare persone così determinate, convinte, piacevolmente impegnate nel proprio lavoro. Non è davvero cosa molto frequente.
Facciamo tanti auguri ad Antonella e alla sua avventura a Madrid.

Regulatory Affairs DI RENZO auf der CPhl 2012 in Madrid

Die Beratungsfirma für Regulatory Affairs Di Renzo wird mit einem eigenen Messestand (10D74, Hall 10) auf der 23. CPhI Worldwide vom 9. bis 11. Oktober 2012 sein.

Diese internationale Veranstaltung zieht tausende von Firmen und Personen aus aller Welt an. Es handelt sich um eine der bekanntesten Messen des medizinischen Sektors, die jedes Jahr in einer anderen Stadt organisiert wird.

Sie bietet den verschiedenen Unternehmen wie Betrieben, die Rohstoffe oder Endprodukte herstellen, Verpackungsfirmen und Konsulenten, die Gelegenheit, sich zu treffen. Außerdem sind zahlreiche Workshops über die Entwicklung der Arzneimittel, dem letzten Stand der gesetzlichen Bestimmungen der verschiedenen Sektoren, die im Folgenden aufgeführt werden und der Vermarktung geplant.

Die Mitarbeiter des Unternehmens Di Renzo (die Englisch, Französisch, Spanisch und Chinesisch sprechen) stehen für die Teilnehmer, die daran interessiert sind, ihre Produkte auf dem italienischen Markt oder in den anderen europäischen Ländern einzuführen, für Informationsgespräche bereit. Die Produktpalette umfasst unter anderem Human- und Veterinärarzneimittel, Medical Devices, medizinisch-chirurgische Bedarfsmittel, Biozide, Kosmetika, Nahrungsergänzungsmittel.

Der Hauptsitz des Unternehmens Di Renzo befindet sich in Rom, andere Zweigstellen sind in Mailand und London eröffnet worden.

Der Mitarbeiterstaff besteht aus 45 Personen, die vorwiegend diplomierte Wissenschaftler sind. Spezielle Abteilungen beschäftigen sich mit Pharmakovigilanz, Vorbereitung von Preis-Dossiers in HTA, Erstellung von Arzneimittelinformationen, CTD und eCTD.

MDs: Italian manufacturers fight spending review

The Italian federation of MD manufacturers decided to take action against some provisions of the Government spending review, whose impact on the sector is considered ruinous.

The measures include a 5% cut on the supply contracts and expenditures until December 31st 2012, the introduction of reference prices and an expenditure ceiling of 4.9% in 2013 and 4.8% in 2014. This would lead to a 2 billions reduction in the public expenditure but also to a 25% loss in the revenues.

The Medical Devices federation intends to file a complaint to the European Community and start an infringement procedure because reference prices violate the principle of renegotiation in public tenders after they have been won.

The federation is also working on a revision of the current reference prices and of those coming into force in 2013 and intends to organize working groups aiming at a better rationalization of resources and to avoid waste.

Finally, cuts to the same organization are expected, with a 5% decrease in the membership fees next year.  
 

Clinical trials: authority transfer from ISS to AIFA

The conversion into Law of the Decree Law no. 158 of 13 September 2012 AIFA will be assigned with the authority for clinical trials previously assigned to ISS by the Legislative Decree 211/2003.

In the meantime, in order to assure the correct carrying out of the activities concerned by these regulatory changes, the Italian Medicines Agency and the National Institute of Health (Istituto Superiore di Sanità - ISS) announced that the ISS will continue to perform the same activities, according to the usual operating modes, electronically informing AIFA about the new requests of authorization for phase I clinical trials, submitted to ISS by the Sponsors.

CEP withdrawal: cyclosporine

Following an inspection by the Finnish Medicine Agency the manufacturing site Taishan City Chemical Pharmaceutical CO. LTD - China resulted as non compliant with the GMPs. Therefore the EDQM withdrew their certificate R0-CEP 2006-223-Rev 01/Cyclosporine.

AIFA Assessment and Authorization Office required all MAHs of medicinal product containing this active substance to urgently check whether this site results as starting material/intermediate/active substance supplier and to send prompt communication to the Agency. MAHs which authorized this site as supplier will have to submit a variation within September 22nd to replace it with another GMP-compliant site.

In case of no communication, AIFA will withdraw the products. The communication should be sent also in case of negative feedback.

New Government Decree published in OJ

The new Decree including measures to assure health protection as well as expense reduction has just been published in the Italian OJ (no. 214 of September 13th 2012).

The decree provides for the reorganization of the NHS and the Ministry of Health, and includes urgent provisions on specific health issues. The most relevant measures include a rearrangement of territory health assistance, new rules for private practice by NHS doctors, an update of the essential care levels and the promotion of healthy lifestyles (smoking and gambling). The decree also provides for interventions and measures on food safety and animal health, hospital building and research, and aims at assuring more transparence in the appointment of NHS general managers and head physicians.

The decree also assures prompt access to innovative reimbursed drugs by patients in all Italian regions. Out-of-date pharmaceuticals will be moved to Class C (not reimbursable) of the National Reimbursement List (PFN), while the price of effective but expensive drugs will have to be renegotiated or theye will be excluded from the the List within 2013. Moreover non authorized drugs will be reimbursable when their safety and indication equals PFN drugs but only if the mean treatment costs are at least 50% lower. Also pilot schemes for new tailored made pack-sizes will be implemented in order to reduce product waste and misprescription.

Finally, the Decree includes updated procedures regarding pharmaceutical and some provisions on homeopatics, veterinary products and hormones.