sMAartblog

Medical & Pharmaceutical

9 Sep 2010

EUDAMED: European Database on Medical Devices

A European Commission decision adopted in April will oblige all EU countries to use, as of May 2011, a European databank for medical devices (Eudamed). Medical devices range from life-supporting devices such as pacemakers through hip implants or X-ray machines, down to products used daily such as syringes or blood tests. Even though these devices are traded on the European single market, data which are key to their safety – such as conformity certificates, data on clinical investigations – are for the time being collected only at the national level. The Eudamed databank is a secure IT tool which will ensure rapid access to such data by market surveillance authorities.

Thanks to rapid communication channels between market surveillance authorities, the risk for patients of a safety incident or malfunctioning will be reduced. In particular, rapidly sharing information on any known incidents will diminish the risk of recurring incidents elsewhere in the EU.

Source: http://europa.eu/rapid/pressReleasesAction.do?reference=IP/10/443&format=HTML&aged=0&language=EN&guiLanguage=en

See more: http://ec.europa.eu/idabc/en/document/2256/5637

21 Apr 2010

Dangerous Translation Errors

New York. Multilingual community. Based on the Ordinance of the Mayor, Michael Bloomberg, all pharmacies are obliged to provide translation of package leaflets for patients speaking one of seven most spoken languages in the city.

How do pharmacies manage this task? A study conducted by two researches in almost 300 pharmacies in the Bronx showed that in about 75% of cases pharmacists did offer translation. However – no matter how unbelievably it may sound – almost 90% of leaflets were translated by computer programmes, and only 3% of pharmacies used the services of qualified translators. No wonder that spelling and grammar mistakes were common. But that is not the biggest problem of that risky idea.

Mistakes made by computer programmes may turn out to be dangerous, especially in case of omissions or wrong information on dosing/contraindications/special precautions for use etc.

Let’s take an example of translation of “once daily”, where English ‘once’ means ‘eleven’ in Spanish. There is at least one documented case when patient took precisely the dose indicated in the translated leaflet, i.e. 11 (eleven) tablets instead of 1 (one). I believe everyone can imagine the possible consequences of such overdosing.

Once again we have a proof that at least in case of such texts, when human health is at stake, a thorough control by qualified translators/experts cannot be omitted, irrespective of constant improvements in translation programmes.

Source: http://www.rynekzdrowia.pl/Farmacja [20 Apr 2010]

20 Jan 2010

“Borderline Products” Still On The Market

In the post of 30 Dec 2009 (LEGAL ISSUES) we have informed about the possibility that as of 1 January 2010 a number of dietary supplements will disappear from the Polish market. However, the supplements belonging to the group of “borderline products” (classified as medicines, food, cosmetics) are still available in pharmacies.

The Ministry of Health has decided that according to the new legal provisions it is only prohibited to sell such products as food. The basis for selection is supposed to be the list of substances which can be used in supplements or medicinal products, published by the Office for Registration.

Source: http://farmacja.e-bmp.pl/

30 Dec 2009

Legal Issues

Dietary supplements

As of 1 January 2010 a number of dietary supplements will have to disappear from the market. The end of this year is the deadline for the manufacturers to re-register the so called “borderline products” (products falling into several categories, e.g. medicines, cosmetics, food supplements etc.) as medicinal products. However, according to the Polish Office for Registration many manufacturers failed to complete the procedure. The possible reason for such situation is the lack of clear criteria to distinguish between supplements and drugs (the Office has published only the list of substances used in supplements/medicinal products, without doses or conditions of use, see: http://www.urpl.gov.pl/suplementynat.asp). The outcome of the new legal requirements is about to be seen in the pharmacies; it is estimated that about half of their products belong to the group of dietary supplements.

Herbal medicinal products

Similarly, changes in the legal requirements will also affect herbal medicinal products. In accordance with the Directive 2004/24/EC – which came into force on 30 April 2004 and is to be fully applied by 30 April 2011 (transitional period of 7 years) – the new definition of herbal medicinal products excludes those containing synthetics. It means that about 500 herbal medicines of Polish manufacturers no longer fall into the category of herbal medicinal products and would require costly re-registration.

There is a chance for some of the manufacturers to avoid complex registration procedure. The EU accepted national approach to the provisions of the Directive, however, marketing authorisation granted for herbal medicinal products containing synthetics – but treated as traditional herbal medicinal products – would be valid only in Poland. Moreover, binding decisions are still to be made by the competent authorities.

Would that mean the shift from herbal medicines to dietary supplements? The future will show.

Source: http://www.rynekzdrowia.pl/; http://farmacja.e-bmp.pl/

17 Dec 2009

Fake Medicines in the EU

The Industry Commissioner, Guenter Verheugen, said in an interview published last week in the German daily Die Welt that the trade in counterfeit medicines in the European Union had exceeded the EC worst fears. “In just two months, the EU seized 34 million fake tablets at customs points in all member countries,” he said. Among the counterfeit medicine were antibiotics and cancer treatments, as well as anti-malaria medicines, analgesics and anti-cholesterol treatments.

The outgoing EU commissioner expressed optimism that there would be progress in tackling the problem of fake medicines in the coming year. He also called for steps that will criminalize offenses and protect potential victims.

Already in June, EU health ministers welcomed a legal proposal aimed at stopping fake drugs entering the legal supply chain. The plan included stepped-up security measures on packaging, including barcodes, seals and holograms, as well as tighter controls on suppliers.

Source: http://www.dw-world.de

9 Dec 2009

Draft Guideline on Validation of Bioanalytical Methods

Committee For Medicinal Products For Human Use (CHMP) has presented a draft guideline on validation of bioanalytical methods. The main focus of the guideline is the validation of the analytical methods used for pharmacokinetic sample analysis.

This guideline provides requirements for the validation of bioanalytical methods. It also covers specific aspects of the bioanalytical method itself, e.g. the actual analysis of samples from toxicokinetic studies and clinical trials.

Background:

The results of toxicokinetic, pharmacokinetic and bioequivalence studies are used to make critical decisions supporting the safety and efficacy of a medicinal drug substance or product. As such they are of crucial importance in medicinal product development as well as for line extensions and generic products. In other words, such data may be required to support new applications as well as variations to authorised drug products. Therefore, fully validated and well documented bioanalytical methods are necessary in order to obtain reliable results.

The draft guideline is now released for consultation; the deadline for comments is 21 May 2010.

Source: Draft guideline: http://www.emea.europa.eu/pdfs/human/ewp/19221709en.pdf [9 December 2009]

8 Dec 2009

EMEA – New Visual Identity and Organisational Structure

On 8 December 2009 the European Medicines Agency (EMEA) officially presented its new organisational structure and new visual identity. It is a second change in Agency’s services since its establishment in 1995.

The main changes in the new organisational structure include:

– the integration of human pre- and post-authorisation activities into one unit

– the creation of a new unit for patient health protection

– a dedicated group for the management of product data and documentation.

From 8 December 2009 onwards, the EMEA website has a new address: www.ema.europa.eu. Old and new addresses will continue to function for a period of one year.

Source: EMEA Press release http://www.emea.europa.eu/pdfs/general/direct/pr/70491809en.pdf [8 December 2009]

27 Nov 2009

eCTD Submissions

The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Poland has announced that from 1 January 2010 it will be possible to submit regulatory dossier via eCTD format (Electronic Common Technical Document).

On the European level, in January 2010 EMEA (European Medicines Agency) plans to introduce mandatory eCTD for the Centralised Procedure submissions.

The eCTD is defined as an interface for industry to agency transfer of regulatory information. The ultimate aims of the European regulatory community, in accepting electronically submitted information using the eCTD, will be to facilitate the review process and ease practical difficulties.

These aims may be further refined as follows:

  • The facilitation of the review process through:
    • Easy viewing;
    • Legibility;
    • Printer friendly formats;
    • Easy and rapid navigation through a table of contents, and links within files;
    • The ability to search (the submission metadata as well as narrative text, and across submissions);
    • The ability to transcribe all types of information for review and analysis; and
    • Improved access to the current information on the product through automatic update
  • The easing of practical difficulties through:
    • The reduction of physical paper flows;
    • The reduction in the requirement for physical storage space during review;
    • The reduction of the requirement for physical archiving space; and
    • The ability to identify and call up archived information easily and rapidly through electronic filing.

Source: http://www.urpl.gov.pl/, http://esubmission.emea.europa.eu/ectd/index.html [23 Nov 2009]

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