Pharma blog: the latest from the industry

On “Pharma Blog”, Diapharm’s corporate blog, members of our staff discuss the current developments and regulatory challenges they face in their areas of expertise. The wide range of topics we cover makes it clear what we are: specialised generalists.

Middeler
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

MDR date of application postponed; MDD remains in force

The European Parliament and the European Council have finally agreed to the EU Commission’s proposal to delay the date of application of the MDR by one year until 26 May 2021. The announcement has already been published in the Official Journal. Manufacturers of medical devices now have more planning security again. Products that have been on the market according to the “old” standards of the Medical Device Directive (MDD) and are not yet MDR-compliant are given another chance. In addition, the Medical Device Coordination Group (MDCG) and the EU Commission have a little more time to prepare comprehensive and target-oriented guidelines for the implementation of the MDR.  more >>
Sibbing, Nicole
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

Trend in phytopharmaceuticals: international regulatory extension!

Pharmaceutical companies are increasingly extending the markets for their herbal medicinal products into other EU states, for example using the decentralised procedure (DCP) or mutual recognition procedure (MRP). There is currently particularly high demand for products in the indication areas of women’s health, pain and prevention, and sedation and sleep. No wonder, because the path to new markets is very short – if you are familiar with the regulatory procedures...  more >>
Stromeier
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

Quo vadis cannabis?

By now, many companies in Germany have applied to their local regulatory authorities, depending on where they have their registered office, for an import permit or wholesale distribution authorisation. Some are currently preparing to file the application or are considering moving into this area. While preparing their applications, these companies will face a disparate range of requirements from the competent authorities in their respective federal states. Following intense preparation, official reviews and initial inspections of the companies’ QM systems and supply chain, many of these import permits and wholesale distribution authorisations will be granted without any major issues. In some cases, however, there may be some unwelcome surprises…  more >>
Klöpf
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

Nitrosamines: EMA publishes list of potential contamination sources

Marketing authorisation holders (MAHs) currently need to test all chemically synthesised medicinal products for nitrosamine contamination. This requirement extends to innovative products, generics and over-the-counter (OTC) products alike. The EMA recently released a list of potential sources of nitrosamine impurities that can help MAHs to identify risks in the manufacturing process.  more >>
Klöpf
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

Nitrosamine: MAHs have only six months of time remaining

Since contamination with nitrosamines caused recalls of yet another substance class a few days ago, the EMA has been concerned as to how far the range of nitrosamine-contaminated medicinal products extends and which products could still be susceptible to such contamination. It intends to obtain an assurance from every Marketing Authorisation Holder (MAH) that no nitrosamines are contained in finished products. MAHs should perform a risk assessment for all of their products within the next six months.  more >>
Middeler
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

Increasing scarcity of notified bodies for medical devices – act now!

Medical device manufacturers who used to be able to rely on their notified body may soon find themselves without products. Manufacturers of medical devices composed of substances and combinations of substances that are being reassigned from class I to a higher medical device class are especially hard hit. They need product certification by a notified body for the first time, along with an audit of the quality management system according to EN ISO 13485:2016. But of formerly more than 80 notified bodies in Europe, many are no longer obtaining accreditation according to the MDR, which means they can no longer carry out such conformity assessments. Diapharm can help!  more >>
Kappenberg
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

The pharmaceutical industry and Brexit – EU retesting within EU borders only from 1 January 2020

Batches of medicinal products to be marketed in the European Union must be tested and released by a QP in the EU27. The official post-Brexit grace period for companies that import medicinal products into the EU from or through the United Kingdom is going to be short. According to the CMDh, companies must have finished relocating their batch testing facilities to the EU27 by 1 January 2020 at the latest. Businesses that fail to comply will risk losing their marketing authorisation. International pharmaceutical companies that import medicinal products into the EU from third countries by way of the United Kingdom are just as affected as British manufacturers that have so far taken care of quality control and batch release for continental Europe within their national borders. Diapharm can help safeguard access to the European market in the short and long term.  more >>
Middeler
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

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 >>
Middeler
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

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 >>
Stromeier
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

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 >>
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

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 >>
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

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 >>
Sandner, Thilo
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

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 >>
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

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 >>
Deckena
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

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 >>
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

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 >>
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

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 >>
Schulte
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

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 >>
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

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 >>
Middeler
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

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 >>
Sandner, Thilo
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

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 >>
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.info

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 >>
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