Press Area

DIA Annual Meeting: Number of traditional herbal medicinal products in the EU increasing only slowly

San Diego (USA), Oldenburg (Germany), 30 June 2009.  Currently, there are 65 traditional herbal medicinal products (THMPs) registered in Europe on the basis of EU Directive 2004/24/EC – 30 of them in the United Kingdom alone, and a further 12 in Austria. Dr. Rainer Kolkmann of pharma service provider Diapharm (www.diapharm.com) presented these figures on Tuesday 23 June at the annual meeting of the Drug Information Association in San Diego, USA. Registrations are still unevenly distributed in the EU, he pointed out. So far, only 7 registrations have been granted in Germany and 2 in Greece, all with comparatively weak indications. Other medicinal product authorities in Italy, France, Portugal or Belgium, for example, are still adopting a ’wait and see‘ attitude. "However, I am confident that most countries will follow the United Kingdom’s example. The number of registered products in this new category of medicinal products will increase rapidly over the next two years”, predicted Dr. Kolkmann.

Dr. Karim Sultan boosts Diapharm’s internationalisation

Münster, 15 June 2009.  Dr. Karim Sultan just joined the Business Development team at Diapharm (www.diapharm.com). The experienced manager specialised in healthcare will support Diapharm’s internationalisation process. He will build up and run a Diapharm subsidiary in the United Kingdom. Diapharm is a leading full service provider for medicinal product manufacturers. The service portfolio consists of services in the area of regulatory affairs, medical affairs, pharmacovigilance, analytics and GMP. Diapharm’s core competence particularly lies within OTC and traditional herbal medicinal products.

After conflicting decisions by the authorities: Diapharm organises GMP audits at Ranbaxy

Münster, 08 May 2009.  In May and June 2009 pharma service provider Diapharm (www.diapharm.com) will perform an audit regarding GMP compliance in the production of seven active pharmaceutical ingredients at the Indian plants of pharmaceutical manufacturer Ranbaxy. Diapharm will make the resulting accredited audit reports available to medicinal product manufacturers under a cost-sharing arrangement. Production of the active ingredients cefaclor, cefpodoxime, cefuroxime, clarithromycin, ofloxacin, ranitidine and sertraline is to be audited.

Accredited GMP audit reports for additional active pharmaceutical ingredients

Münster, 23 March 2009.  During March 2009, pharma service provider Diapharm (www.diapharm.com) has commissioned audits of GMP compliance in the production of the active pharmaceutical ingredients Caffeine, Theophylline, Phenazone, Metamizole-Sodium and Trimethoprim by manufacturers in the Shandong region of China. Diapharm will make the resulting accredited GMP audit reports available to European medicinal product manufacturers under a cost-sharing arrangement.

Diapharm consolidates leading position in traditional-use herbal registrations

Marlow (UK), Oldenburg (DE), 18 March 2009.  The decision by the British regulatory agency MHRA on "RelaxHerb” in early March 2009 was double cause for celebration, in Marlow in the UK and in Oldenburg, Germany: firstly by registration holder Schwabe Pharma (UK) Ltd. which, with the traditional herbal medicinal product, now has in its portfolio a product for alleviating symptoms associated with stress. And secondly by regulatory service provider Diapharm (www.diapharm.com) which prepared the necessary quality dossier and evidence of traditional use for Schwabe. RelaxHerb is the thirteenth United Kingdom registration managed by Diapharm: "Every second traditional herbal medicinal product there is registered on the basis of dossiers from our company”, emphasises Diapharm General Manager Dr. Rainer Kolkmann.

Diapharm receives four traditional herbal medicinal product registrations for sleep disturbances

Münster, Oldenburg (Germany), 14 January 2009.  Registrations for four new traditional herbal medicinal products for the treatment of sleep disturbances have just been granted to the pharma service provider Diapharm (www.diapharm.com) by the British regulatory agency MHRA. The registrations for DiaNight, DiaNight Plus, DiaSleep and DiaSleep Plus are to be offered for sale.

Food supplements: EU Commission does not want to regulate "other substances"

Münster (Germany), 22 December 2008.  A Europe-wide positive list for substances other than vitamins and minerals in food supplements is probably off the cards. The EU Commission, in a report to the Council and the European Parliament (COM/2008/0824), states that specific rules are "not justified". "The restriction of botanicals such as artichoke extract, lycopine, or polyphenols and of other substances, such as probiotic cultures, which was being feared by the industry thus seems to have been averted," explains Ursula Schäfer of pharma service provider Diapharm (www.diapharm.com): "Food supplements will in future continue to differ, national distinctions will remain for the time being."

Increased efficiency and clear interpretation: experts discuss stability testing of medicinal products

Vienna (AT), Oldenburg (DE), 2 December 2008.  Authority representatives and pharmaceuticals experts from Europe, the USA and Canada discussed current experiences with the stability testing of medicinal products on 25th and 26th November 2008 in Vienna. The conference titled "Stability Testing for Pharmaceuticals" focused both on questions of interpretation of the guidelines on which the testing is based, and on specific proposals for the implementation of testing. Dr. Jürgen Mählitz of the Upper Bavaria medicines authority gave a presentation on the expectations and experiences of a GMP inspector in respect of ongoing stability testing. Dr. Sven Oliver Kruse of the German pharmaceutical service provider Diapharm (www.diapharm.de) explained how these requirements can be put into practice in a focused and economical way. Since June 2006, pharmaceutical companies in Europe have been required to monitor the stability of their medicinal products during the marketing phase in a continuous programme. The initial findings from this experience were discussed at the conference.

Utilising cost reduction opportunities: Conference on "Optimising Stability Testing" in London

Münster, 25 September 2008.  International experts discussed how to realise more efficient stability tests for medicinal products last Thursday and Friday (18 and 19 September) in London. At the two-day "Optimising Stability Testing" conference Dr Sven Oliver Kruse, managing director of Diapharm Analytics GmbH (www.diapharm.com), was one of those explaining how the burden of ongoing stability tests can be reduced with improved study design. All medicinal products on the market must be monitored in a continuous programme in order to demonstrate stability and quality over their entire market life.

Diapharm starts GMP audit service for active pharmaceutical ingredients

Münster (Germany), 11 September 2008.  Pharma service provider Diapharm (www.diapharm.com) is now offering accredited shared third-party audits for active pharmaceutical ingredients (APIs). In a shared audit several medicinal product manufacturers jointly commission the check of production conditions for a starting material or API such as ibuprofen or naproxen. The resulting audit report serves to prove whether the rules of good manufacturing practice (GMP) are followed in the manufacture of the ingredient. This proof of GMP compliance is mandatory for European manufacturers of medicinal products. "Accredited third-party audits offer additional security, since they are also recognized internationally by the authorities”, explains Dorothee Klöpf of Diapharm, responsible for the GMP audit service. For these checks Diapharm collaborates with the independent, accredited blue inspection body GmbH. Upon request, blue also undertakes the management of deficiencies.