Current press releases

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General Manager of Diapharm Ralf Sibbing discussed the impact of the upcoming Brexit at CPhI China, which took place in Shanghai from 20 to 22 June 2017. His presentation focused on the preparations of Chinese pharmaceutical companies aimed at launching products on the European market. “The volatility caused by the United Kingdom’s upcoming exit from the EU is already having an impact on the decision-making processes of providers from third countries,” Ralf Sibbing remarked in Shanghai.

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The healthcare consultancy Diapharm (www.diapharm.com) announces the arrival of Dr Thilo Sandner, an experienced business consultant, to its team. Prior to joining Diapharm, Thilo Sandner gained considerable experience in the global Life Sciences team of Charles River Associates (CRA), formerly Cepton Strategies, in their Munich and New York City offices. During his time at CRA, he managed projects on portfolio and commercial strategies, as well as market access. At Diapharm, he will assume a leading role in the strategic management consulting team.

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“Europeans think highly of Traditional Chinese Medicine, but so far only a few TCM products have made their way into the EU”, observed Diapharm’s Dr Rainer Kolkmann at the 5th International Conference on the Modernization of Traditional Chinese Medicine (TCM) in Chengdu, China. But Kolkmann also said that the European Medicines Agency and its Committee on Herbal Medicinal Products, HMPC, are “open-minded” to TCM products coming to Europe: “The harmonisation of assessment practices for herbal substances of non-European origin is explicitly included in their work programme.“ In his speech, the Head of Product Development at one of Europe’s leading regulatory service providers (www.diapharm.com) explained how to successfully register TCMs in the European Union. Dr Rainer Kolkmann had been invited as a foreign vice president to the conference’s TCM innovation panel. The conference with 1,500 participants took place on 24-25 October in Chengdu, the capital of Sichuan Province, China.

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The pharmaceutical service provider Diapharm has succeeded in obtaining traditional-use registration for a combination product containing St John’s Wort and Valerian extracts for the treatment of mental exhaustion (fatigue) and related sleep disturbance. Until now, the time-consuming marketing authorisation process was the only path to being able to market products containing St John’s Wort and Valerian. For the first time, Diapharm has been able to register with the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) a combination product consisting of both active pharmaceutical ingredients (APIs) with an appealing indication and a consumer-friendly dosage. The combination product is available for licensing.

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Seven EU member states have approved a new traditional herbal medicinal product (THMP) containing Hypericum (St John’s Wort) and Cimicifuga racemosa (Black Cohosh). Idelyn will be marketing the THMP “for the relief of symptoms of the menopause, including hot flushes, night sweats, also profuse sweats, slightly low mood and mild anxiety based on traditional use only”, which was developed by pharmaceutical services provider Diapharm, in Hungary, Bulgaria, Estonia, Lithuania, Romania, Slovakia and the Czech Republic. These seven countries opted for registration in what is known as a voluntary decentralised procedure (DCP). Diapharm has also prepared further national authorisation applications on behalf of Idelyn.

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Diapharm, the global service provider and consulting firm for the pharmaceutical industry (www.diapharm.com), is intensifying its business with clients from China. It recently accompanied Huasun Group Pharmaceutical Factory (China), along with Dr. Mei Wang of SU BioMedicine (Netherlands, a TNO company), to the German medicines authority BfArM for a scientific advice meeting on their Sanchi-tongshu capsules. The product is on the way to become the first Traditional Chinese Medicine, or TCM, to be registered via a full application in Europe.

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Dr Hartmut Kley has joined Diapharm (www.diapharm.com) as Senior Manager Pharmacovigilance, marking an additional expansion of the pharmaceutical service provider’s activities in the field of drug safety. The company monitors and evaluates the risk/benefit profile of medicinal products on an ongoing basis on behalf of its clients, compiles the required safety reports (PSURs, PBRERs), conducts pharmacovigilance audits and assumes responsibility for a number of roles, such as qualified person for pharmacovigilance. “We see great potential in this field,” says Diapharm founder Dr Stefan Sandner. “As a result, we are particularly pleased to have been able to attract an extremely experienced consultant and auditor such as Dr Hartmut Kley.”

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Dr Sven Oliver Kruse has been appointed Central Director at pharmaceutical service provider Diapharm (http://uk.diapharm.com) and is responsible for central sales with immediate effect. “Solid customer relationships are absolutely essential for a consulting and services company such as Diapharm,” says Dr Sven Oliver Kruse. “By creating the role of Central Director, we have established a function to offer our clients our full range of services from a single source.”

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The pharmaceutical service provider Diapharm’s third-party audit service (uk.diapharm.com/audits/) has now exceeded the mark of 500 current GMP audit reports. On behalf of the pharmaceutical industry, auditors check on site whether suppliers of active pharmaceutical ingredients (APIs) worldwide are complying with Good Manufacturing Practices. From the manufacturing of acetylcysteine in Spain to zolmitriptan in India, almost all of Diapharm’s audit reports are available for purchase. A small amount of audits are performed exclusively for individual clients.

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The pharmaceutical service provider and consulting firm Diapharm (www.diapharm.com) has recruited Dr Stefan Leyers to join its regulatory division. He will advise pharmaceutical companies on national and international regulatory matters and assist them in establishing and maintaining the related dossiers. Dr Leyers is a registered pharmacist who has also earned a doctorate. “We are thrilled to have another highly qualified marketing authorisation expert on board who is the perfect addition to our Regulatory Affairs team,” says Ralf Sibbing, General Manager of Diapharm.

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Münster (DE), 7 October 2015 – Dr Jan Winters is the new Senior Manager Regulatory Affairs Food Supplements at Diapharm (www.diapharm.com). He will assist Diapharm clients with the development, evaluation and maintenance of food supplements. Prior to this position, Dr Jan Winters worked for the pharmaceutical industry as a regulatory affairs consultant on the development of food supplements, dietetic foods and functional foods, among others. He completed his degree in nutritional science and earned a doctorate from Leibniz Universität Hannover on the topic of the legal demarcation of food stuffs and medicinal products.

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The European Union is one of the most important pharmaceutical markets globally. The market size of the EU-15 countries alone reached USD 134 billion in 2013. In 2014, the pharmaceutical trade between China and Europe reached USD 33.2 billion, with finished medicinal products accounting for USD 9.3 billion. As the export amount to EU was only USD 450 million, the composition of trade needs to be upgraded and enhanced.

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Diapharm’s offices in China (http://cn.diapharm.com) are moving: “Our activities in Asia are developing very positively,” says General Manager Ralf Sibbing. “We will continue to expand this presence with our new office on XianXia Road in Shanghai.” Diapharm supports medicinal product manufacturers in the marketing authorisation and maintenance of medicinal and healthcare products in its role as a consultancy firm and a pharmaceutical service provider. In China, Diapharm is a point of contact for the roughly 2,400 member companies of the China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE).

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SU BioMedicine and Diapharm have signed a strategic collaboration agreement for bringing Chinese Medicine faster and more widely spread into the EU market. Both companies have already been managing marketing authorisation processes for Traditional Chinese Medicines (TCM) in European countries. Together, they will become the leading party for registration and distribution of TCM in Europe. "Dedicated to the improvement of health care, SU BioMedicine is proud to have Diapharm as strategic partner to accelerate the introduction of high quality products for cure and care into the European market", said Jan van der Greef, PhD, CEO of SU BioMedicine.

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Dr Serap Açikgöz took over as head of the laboratory team at Diapharm Analytics GmbH in late February 2015. The service laboratory of Diapharm (www.diapharm.com) supports pharmaceutical companies in analytical quality control. In addition to stability and batch release testing, the company also provides method development and method validation services to ensure the quality of Diapharm clients’ medicinal products.

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A new provider of clinical studies and strategic consulting has entered the field to revolutionise the market for over-the-counter (OTC) medicines and related products. Orange OTC Research (www.orange-otc.com) is the first clinical research organisation (CRO) to focus specifically on consumer healthcare in Europe. The company wants to become an initiator of “new, intelligent, scientifically supported product claims”, as co-founder Dr. Stefan Sandner emphasises.

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Pharmaceutical service provider Diapharm is restructuring its senior management. Ralf Sibbing will continue as sole General Manager. Martin Vortkamp will leave the company by mutual agreement. Diapharm founder Dr. Stefan Sandner cited a difference in opinion regarding the strategic focus of Diapharm as a leading service provider and consulting firm for the consumer healthcare and pharmaceutical industry as the reason for the decision. Martin Vortkamp joined Diapharm in 2009 and held a variety of positions at the company before being named Co-General Manager in 2012.

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On 1 July, Diapharm (www.diapharm.com) has opened its representative office in Shanghai in reaction to a surging demand for pharmaceutical consultancy services in China. Diapharm helps pharmaceutical companies to obtain drug approval in Europe and assists them in quality assurance. “We will advise and assist Chinese companies as they make their way to Europe and also support European companies that purchase active ingredients or finished products from China and that may require assistance in auditing their suppliers,” Ralf Sibbing, general manager of Diapharm, explains.

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Pharmaceutical service provider Diapharm (www.diapharm.com) is increasing its business activities in China: Diapharm has now implemented a “European” quality management system for Neptune Pharma Ltd (www.neptunepharma.com) in their Joint Venture Partner’s factory in Ningbo, Zhejiang Province. And it has done so successfully: The veterinary medicinal product Trident 500mg/g Powder for Suspension for Fish Treatment (www.trident-50.com), is manufactured onsite under EU GMP standards. Trident has Marketing Authorisations in the UK & Norway to combat fish lice. It is set to hit the market in December 2013.

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Pharmaceutical service provider Diapharm (www.diapharm.com) has developed a marketable probiotic medical device. The hard capsules with Lactobacillus johnsonii EU1 are used for the regeneration of the mucosal function of the small intestine, e.g. due to persistent non-specific diarrhoea or due to antibiotic-induced diarrhoea. The probiotic product is now available in Belgium under the brand of a large pharmaceutical company. Diapharm is currently searching for suitable licensing partners in other EU member states or is in negotiations regarding market introduction.

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Pharmaceutical service provider Diapharm (www.diapharm.com) is opening a branch office in China in 2014. Ralf Sibbing, managing director of Diapharm, announced the decision during the visit of Dr Xu Ming, the vice president of the Chinese Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE), to Münster. Dr Xu, who is the representative of 2,400 Chinese pharmaceutical companies, met with the Mayor of Münster, Markus Lewe, among others on Thursday (19 September). Xu Ming made the trip to Münster to hold talks with pharmaceutical companies, which, apart from Diapharm, also included Wessling, the Altenberge-based laboratory services corporate specialist, and pharmaceutical auditor blue inspection body GmbH from Münster.

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For the first time the French regulatory authority, Agence nationale de sécurité du médicament et des produits de santé (ANSM), has registered a traditional plant-based combination medicine. The product is presented as a coated tablet, with the three active substances Valerian, Passionflower and Melissa. ANSM granted the indication: for the relief of mild nervous tension and sleep disorders („Médicament traditionnel à base de plantes utilisé pour soulager une tension nerveuse légère et les troubles du sommeil. Son usage est réservé à l’indication spécifiée sur la base exclusive de l’ancienneté de l’usage“). The medication was developed by pharmaceutical provider Diapharm (www.diapharm.com), and is brought to market by FORTÉ PHARMA, Monaco, under the brand name Dormicalm.

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At a 3-day workshop in Cairo, pharmaceutical service provider Diapharm (www.diapharm.com) presented the European regulations on medication demarcation areas to representatives of the Egyptian Ministry of Health. Currently, Egypt is revising its legislation regarding medical products, nutritional supplements and self-medication products and is considering, at least partially, taking into account EU legislation. The objective is to improve the availability of safer products.

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DSM Nutritional Products and DSM Pharmaceutical Chemicals have mandated Diapharm GmbH to carry out bundled audits on the production of numerous vitamins, medical pharmaceuticals and fatty acids in compliance with the European Guide to Good Manufacturing Practice (GMP). The arrangement will allow the company to more efficiently structure the regularly required GMP audits. In the coming weeks, pharmaceutical service provider Diapharm will organise monitoring of the manufacturing processes of DSM production sites in Grenzach (Germany) and Dalry (UK). The auditing process began at DSM Pharmaceutical Chemicals in Linz (Austria) on September 4th and 5th, 2012.

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