The COVID-19 pandemic significantly accelerated the adoption of decentralized clinical trials. As health system resources were expended on COVID-19-related care and travel became limited by physical distance, patient access to research facilities decreased by 80 percent.[1] In the face of such disruptions, sponsors quickly mobilized to maintain continuity of care and data integrity – for example, by adopting remote patient consent and monitoring. Although some elements of decentralization of clinical trials existed before the COVID-19 pandemic, they were not widely used in trials. And as the global pandemic continues, a consensus is emerging that many interventions will become permanent. Tools such as electronic consent, telehealth care, remote patient monitoring, and electronic clinical outcome assessments (eCOAs) make it possible to maintain contact with study participants without in-person visits.

Defining decentralized clinical trials and trying to understand them

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Polish companies are willing to start selling cosmetics in China, however still some formal requirements stand in the way. China has recently changed its cosmetics industry regulations. Until May 1 2021, China required importers to test cosmetics on animals. It was an insurmountable barrier for European producers, because the European Union has been banned from testing cosmetics on animals for many years. Now the Chinese are demanding a certificate of Good Manufacturing Practice. It is to certify that the preparation was developed under the conditions and standards imposed by an international standard. Such certificate should be issued by the supervisory authority. The Polish certificate has not yet been created, although its content was proposed by the Polish Union of the Cosmetics Industry during the summer holidays in 2021. The Union brings together over 220 companies, including manufacturers, distributors, laboratories, consulting companies and teaching centers.

Without a proper certificate and without an efficient procedure for issuing it, the Polish cosmetics industry loses its competitiveness against other Western countries on the world’s largest market.

Experts in Poland emphasize at the same time that the certificate is not everything. It is still necessary to develop an instruction for its issuing, which will go to the poviat (local level) health care centers.

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The Polish medical and pharmaceutical industry has a long tradition. In recent years, its structure and dynamics have changed significantly. The domestic pharmaceutical industry is one of the strategic industries of the Polish economy. It plays a key role in the whole healthcare system, providing Polish patients with examined, effective, high-quality and affordable medicines. Most Polish pharmaceutical companies have been privatized and numerous companies have been taken over by large foreign pharmaceutical corporations. In addition, new successful companies are emerging, which thanks to their innovation and implementation of new technologies, are entering foreign markets and becoming competitors of foreign companies. They also contribute to a significant increase in the competitiveness of the Polish economy.

Development in figures

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The team of KIELTYKA GLADKOWSKI dedicated to clients operating in life science sector actively advises on all aspects of in vitro diagnostics, including regulatory, corporate and investments matters. For the purposes of such clients this text analyses the bullet points of REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Regulation 2017/746/EU (IVDR) replaces the existing Directive 98/79 / EC on in vitro diagnostic medical devices (IVDD), which was adopted in 1998.

With the publication of the IVDR, the five-year transition period from the In Vitro Diagnostic Medical Devices Directive (98/79/EC) (IVDD) to the new regulation has started. The IVDR regulation will apply from the date of application, i.e. from May 26, 2022, with some provisions, including Notified Bodies and the Medical Device Coordination Group will enter into force sooner. Until the date of application of the IVDR, the laws and regulations adopted by the Member States under the IVDD will continue to apply. Under Art. 22 of the 1998 IVDD directive, the member states were obliged to prepare and introduce the national laws, regulations and administrative provisions necessary to comply with this directive by December 7, 1999 (IVDD) at the latest. The provisions of the directive were to apply with effect from 7 June 2000. As the provisions of the directive could be interpreted differently in different countries, it was possible for national provisions to differ. In the case of EU regulations, the provisions contained therein do not have to be transposed and adapted to national law. In May 2017, the European Parliament and the Council of the European Union published two new regulations on medical devices (2017/745/EU) (MDR) and in vitro diagnostic medical devices (2017/746/EU) (IVDR). Regulation 2017/746/EU (IVDR) replaces the existing Directive 98/79/EC on in vitro diagnostic medical devices (IVDD), which was adopted in 1998.

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KIELTYKA GLADKOWSKI is proud of the fact that we advise on regulatory matters concerning the most modern pharmaceuticals and therapies in the world, including those related to cell and gene therapies. We work for our corporate clients at all stages of their development, from inception to IPOs.

We try to broaden the knowledge necessary to understand the needs of our clients. An example is the analysis of a report concerning the market and novelties of gene and cell therapies in the United States. The purpose of this article is not to describe specific diseases, but for the purposes of legal services, we focus in such analyses on technologies and types of state-of-the-art therapies.

We invite you to read the text containing specific examples, names of therapies, companies, etc. This text is based on the report prepared by the STAT organization, which is a premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. They focus on policy developments in the US, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. The entire report can be reached here:

The future of cutting-edge gene and cell therapies is changing novel approaches and changing the trajectory of treating cancer, lethal genetic diseases and other devastating diseases. But these innovations also come with their own set of challenges, including access issues. The high prices of such therapies, which have entered the market in recent years, and the expected high development costs of others, raise questions about how healthcare systems, payers and patients will pay for treatment.

FDA approves the first personalized cell therapy for patients with: Multiple myeloma.

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