Pharma blog: the latest from the industry

07/16/2019 | Dr. Guido Middeler | Diapharm GmbH & Co. KG | | https://diapharm.co-operate.net

Diapharm secures market access for medical devices containing living microorganisms

Medical devices containing living microorganisms may still be placed on the market, even after 26 May 2020. Diapharm has won court proceedings ascertaining legal security: The transitional regulations of the Medical Device Regulation also apply to products containing living organisms like lactobacilli to restore the natural flora of the vagina and similar medical devices consisting of substances and combinations of substances.  more >>

06/25/2019 | Dr. Guido Middeler | Diapharm GmbH & Co. KG | | https://diapharm.co-operate.net

Medical devices and the OEM/PLM dilemma: Diapharm offers conformity assessment body services

Beginning on 26 May 2020, manufacturers who have used the traditional OEM/PLM approach based on ZLG document 3.9 B16 will face a fundamental problem: Due to the abolition of Article 11, paragraph 7 MDD, it will no longer be possible to simply refer to the original manufacturer’s certificates within the scope of one’s own conformity assessment. As a result, legal manufacturers must themselves assess or receive an assessment of the conformity of the product. They will also need to be able to demonstrate this assessment to their notified body and, if applicable, to the responsible competent authority in such a way that these bodies or authorities are convinced of its correctness. It therefore has to be possible to submit the complete technical documentation of the medical devices in question – including the previously “closed part” containing all trade secrets of the original manufacturer – to the notified body and, if applicable, to the competent authority. This constitutes a threatening situation for both parties due to the reluctance to hand over trade secrets, especially to companies with an economic incentive to make further use of such secrets. Both parties risk losing business should the original manufacturer not be prepared to give the third party full access to the technical documentation. Diapharm now offers a validated solution to this tricky legal problem with its new Trustee Assessment Service conformity assessment body.  more >>

05/24/2019 | Dr. Stefan Stromeier | Diapharm GmbH & Co. KG | | https://diapharm.co-operate.net

German cannabis growers are selected – but the amounts of cultivated cannabis won’t be sufficient

The course has been set for the cultivation of medicinal cannabis in Germany. The cannabis agency at the German Federal Institute for Drugs and Medical Devices (BfArM) has granted three producers a total harvest of 2.6 tonnes of medicinal cannabis per year. The winners of the tender procedure are a German start-up company (part of a Canadian joint venture) and two German subsidiaries of Canadian cannabis manufacturers that will now also be employing their expertise in Germany. However, it is already clear that the German production volume will not be sufficient to cover the foreseeable demand. Germany will therefore remain dependent on imports for some time to come, with the export of “Cannabis Made in Germany” a similarly distant reality.  more >>

05/07/2019 | Diapharm GmbH & Co. KG | | https://diapharm.co-operate.net

Expertise upgrade: outsourcing regulatory affairs in the pharmaceutical industry

Outsourcing certain tasks may be interesting for pharmaceutical companies of all sizes, for a variety of reasons. Companies often make use of outsourcing during transitional phases such as relocation, in urgent situations that can lead to an increased workload, or to cope with short-term understaffing due to employee illness or pregnancy, among other factors. But outsourcing can also pay off in the long term. Large companies can take advantage of outsourcing to reduce headcount and fixed costs for staff, whereas smaller companies that are unable to rely on economies of scale can turn to experts to take over duties that do not come up every day. What is more, companies of all sizes can benefit from the additional expertise that outsourcing offers.  more >>

03/22/2019 | Diapharm GmbH & Co. KG | | https://diapharm.co-operate.net

Diapharm Analytics extends its BtM license to include cannabis

The GMP-certified contract laboratory Diapharm Analytics has expanded its narcotics license to include cannabis. In the future, we can offer our customers the analytic according to the current DAB monograph "Cannabis flos". These are the analytical parameters of identity, content and purity. The specifications of the Ph.Eur. monograph "herbal drugs" including the analysis of pesticides, heavy metals, aflatoxins and microbiological purity can also be investigated.  more >>

08/14/2018 | Dr. Thilo Sandner | Diapharm GmbH & Co. KG | | https://diapharm.co-operate.net

The right Brexit strategy: preparing medicinal products and medical devices for the EU27

Let’s be optimistic and say that a “No deal” Brexit is a threat nobody wants to carry out. Pharmaceutical companies from the United Kingdom then have another two years to prepare their medicinal products and medical devices for continued marketability on the other side of the English Channel. The implementation period will end in 2020. That’s sufficent to develop a long-term access to the EU27 market following Brexit. We reveal which aspects companies need to consider now – and where the pitfalls are lurking.  more >>

08/08/2018 | Diapharm GmbH & Co. KG | | https://diapharm.co-operate.net

Pharma and Brexit: an update

The British MHRA recently published some “Guidance” relating to the impact that a transitional agreement would have on the healthcare sector if it became part of the final Withdrawal Agreement. Ultimately, the many “what ifs” mean that everything could stay the way it is. However, barely seven months before Brexit is supposed to take place, a lot is still unclear. Just last year, we reported on the relationship between the pharmaceutical industry and Brexit with the headline, “the clock is ticking”. This headline is now more relevant than ever before.  more >>

06/28/2018 | Silvia Deckena | Diapharm GmbH & Co. KG | | https://diapharm.co-operate.net

eCTDs are now mandatory for FDA submissions

eCTD (electronic Common Technical Document) submissions become more and more common and are already mandatory for several types of procedures and marketing authorisation applications in the European Union. Now, eCTD has become the standard format for applications, amendments, supplements and reports for different types of submissions in the United States as well. A short overview for applicants and marketing authorisation holders.  more >>

05/19/2018 | Diapharm GmbH & Co. KG | | https://diapharm.co-operate.net

Update to the EU Falsified Medicines Directive

Pharmaceutical companies should waste no time in checking whether their medicinal products have been properly – or perhaps even incorrectly – described as “requiring serialisation” by the BfArM, the German authority for medicinal products. The EU Falsified Medicines Directive applies to most medicinal products, but particularly to prescription medicinal products. However, non-prescription medicinal products may also fall under its scope of application.  more >>

04/23/2018 | Diapharm GmbH & Co. KG | | https://diapharm.co-operate.net

The pharmaceutical industry and Brexit: the pseudo transition period

The DIA EuroMeeting in Basel, which just concluded, once again made it clear that the Brexit transition period for pharmaceutical companies means practically no extension. Several key provisions are set to expire in less than a year on 29 March 2019. During the meeting, Hugo Hurts, Head of the Brexit Task Force of the Heads of Medicines Agencies (HMA), even encouraged pharmaceutical companies to assume that the United Kingdom will receive “third-country” status in future.  more >>

03/26/2018 | Eimear Schulte | Diapharm GmbH & Co. KG | | https://diapharm.co-operate.net

How to ensure the highest level of independence in audits (of APIs)

The level of independence of an audit is crucial in order to demonstrate sufficient absence of conflict of interest. What is the most independent audit procedure? How can it be ensured that an audit is neither influenced by the manufacturer (API supplier) who will be audited nor the client who requires the audit? Let us consider the various options available.  more >>

12/14/2017 | Diapharm GmbH & Co. KG | | https://diapharm.co-operate.net

Pharma and Brexit: "Nothing is agreed until everything is agreed"

The future relationship between the United Kingdom and the European Union remains completely unclear, even after the “breakthrough” in the first phase of the Brexit negotiations announced on 8 December 2017. The joint statement by the parties involved in the negotiation makes this perfectly apparent in a single sentence: “Nothing is agreed until everything is agreed.” At the same time, Brexit is increasingly becoming a reality following the announcement of the EMA’s move to Amsterdam. On Friday, 29 March 2019, the United Kingdom will leave the European Union, leaving pharmaceutical companies with a little over 16 months to adapt to the new situation. The EMA is already preparing for the worst-case scenario – a hard Brexit.  more >>

11/15/2017 | Dr. Guido Middeler | Diapharm GmbH & Co. KG | | https://diapharm.co-operate.net

Dermal fillers: collagen and hyaluronic acid injectables are now class III medical devices

The new Medical Device Regulation (MDR) will have a major impact on manufacturers of injectable soft tissue fillers, or dermal fillers, containing hyaluronic acid, collagen or other related substances. Products without a medical purpose will be subject to the MDR in future just like medical devices. This means that dermal fillers are to be classified as class III, the highest risk class, if their ingredients are absorbed – as is the case with hyaluronic acid and collagen. The products must be CE certified by a notified body to allow them to continue being marketed after 26 May 2020. To do so, manufacturers will require documentation including clinical evaluation in accordance with MEDDEV as well as an appropriate quality management system. Dermal fillers will also need to fulfil common specifications that are currently being developed by the EU Commission. The complexity of the processes could lead to bottlenecks and marketing stops. Time is running out!  more >>

09/08/2017 | Dr. Thilo Sandner | Diapharm GmbH & Co. KG | | https://diapharm.co-operate.net

Pharma and Brexit – the clock is ticking

Brexit is approaching rapidly. From 23 March 2019, the United Kingdom will no longer be a member of the European Union. Overnight, medicinal products and medical devices that do not comply with this new reality will suddenly no longer be marketable (without restrictions). Many details still remain unclear, especially the regulatory steps manufacturers will have to take with their medicinal products to avoid losing markets and revenue. Marketing authorisation holders therefore have no other option but to prepare for the worst-case scenario.  more >>

06/12/2017 | Diapharm GmbH & Co. KG | | https://diapharm.co-operate.net

Brexit and pharma: what is to come for pharmaceutical companies once the UK leaves the EU

The upcoming Brexit means a number of challenges for pharmaceutical companies that market their products in the United Kingdom and the European Union. We have summed up the key challenges for “pharma Brexit” from today’s perspective.  more >>

05/11/2017 | Diapharm GmbH & Co. KG | | https://diapharm.co-operate.net

Traditional Chinese medicine in Europe: Symposium organised by CCCMHPIE and Diapharm

Growing numbers of manufacturers of traditional Chinese medicine (TCM) want to sell their products in Europe. However, EU regulations for medicines create numerous hurdles for TCM products, which have a 2,000-year tradition in China. That is why Diapharm partnered with the China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) to organise a “TCM Internationalisation Symposium” on 11 May 2017 in Beijing. The aim was to help Chinese pharmaceutical companies prepare for the opportunities and challenges of European market entry.  more >>

09/12/2016 | Silvia Deckena | Diapharm GmbH & Co. KG | | https://diapharm.co-operate.net

Pyrrolizidine alkaloids in herbal medicinal products: risk assessment and minimization

Drug regulatory authorities currently request the suppliers of herbal medicinal products in Europe to provide risk assessments and measures for risk minimization regarding pyrrolizidine alkaloids (PAs). We implement the requirements for many herbal medicinal products in total Europe. The approaches of individual EU countries are somewhat different.  more >>

08/08/2016 | Dr. Guido Middeler | Diapharm GmbH & Co. KG | | https://diapharm.co-operate.net

Medical device regulation – changes to substance-based medical devices on the horizon

25 May 2016 will go down as a significant date in the history of the European healthcare industry. This was the day when the European Council, Parliament and Commission reached agreement as part of the informal trialogue negotiations on a consensus document poised to pass through the legislative procedure for a new medical device regulation (MDR) in autumn 2016. Substance-based medical devices are expressly recognised as such for the first time in the consensus document. However, plans call for assigning the vast majority of substance-based medical devices to higher risk categories, which means they will need to meet more stringent essential requirements and will find themselves subject to certain regulatory uncertainties. We have compiled the most important points.  more >>

07/03/2015 | Diapharm GmbH & Co. KG | | https://diapharm.co-operate.net

Building bridges between Chinese and European pharmaceutical culture

As one of the world’s largest pharmaceutical industry exhibitions, CPhI China offers an ideal opportunity for exchange between developers, producers, marketers – and cultures. I once again had the privilege of being able to speak at the 2015 conference in Shanghai at CCCMHPIE’s invitation. This year, I talked about current and future changes in European pharmaceutical legislation.  more >>