We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
We are living in very unpredictable times. The virus SARS-CoV-2 is keeping the global pharmaceutical industry, including regulatory agencies, very busy. The whole industry is working together in the development of treatments and vaccines. The process of getting these treatments approved and to patients as quickly as possible requires the undivided attention of regulatory agencies, such as the FDA and EMA. As a result, the following deadlines have been extended for certain other requirements.
Medical Device Regulations (MDR): 26 May 2020 was meant to be the final application of the new Medical Device Regulations in Europe. In light of the current situation, the European Parliament has stated:
Given the current pressure on national health authorities and manufacturers of medical devices, there is a fear that there could be shortages or delays in getting the medical devices needed to fight COVID-19, were they to follow the new rules of the Medical Devices Regulation from May this year.
Based on this, the Parliament adopted the proposal to postpone the application by one year by urgent procedure. The new deadline is 26 May 2021. Note that the new proposal still needs to be adopted by the member states and published, which is expected by 26 May 2020.
Nitrosamines: 26 March 2020 was meant to be the deadline for marketing authorization holders (MAH) to submit to EMA risk evaluation outcomes on nitrosamines in human medicinal products containing chemically-synthesized active pharmaceutical ingredients. This requirement arose from the finding of elevated levels of different nitrosamines in various “sartan” drugs, most recently in ranitidine and nizatidine. Initially, the first submission (identifying whether or not nitrosamines are present) was due by 26 March 2020, with an additional submission providing confirmatory testing, risk evaluation, root cause analysis and a safety limit calculation due by 26 Sept 2022. Having received numerous “reports of the challenges encountered in meeting the original deadline of 26 March 2020, and the impact of the severe restrictions in place to combat the COVID-19 pandemic”, EMA has extended the first deadline to 1 Oct 2020. In the meantime, EMA stated:
There is a very low risk that nitrosamine impurities at the levels found could cause cancer in humans.
West is closely monitoring these developments and is continuously working on supporting customers with relevant data and documents.
During the 14 June 2022 Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) Health Council concerns were raised regarding the challenges facing the implementation of Regulation (EU) 2017/745 (the Medical Device Regulation (MDR)) and the potential impact to the continued availability of certain medical devices on the EU market. Subsequently, at the 9 December 2022 EPSCO Health Council-<sup>1</sup>, the European Health Commissioner, Stella Kyriakides, proposed an urgent, targeted legislative initiative to amend the transitional provisions provided for in Article 120 of the MDR<sup>2</sup>.
<em>Technical Guideline for Study of Nitrosamine Impurities in Chemical Drugs (Trial)</em> was issued by the China National Medical Products Administration on 8 May 2020. This guideline discusses nitrosamine impurities in drug products, including the sources of nitrosamine impurities and the control strategy. The control strategy is given from the perspectives of the basic concept of control, control limits, establishment of analytical methods, and control of risk throughout the drug product lifecycle.
The European medicines regulatory system is based on a network of around 50 regulatory authorities from 30 EEA (European Economic Area) countries (27 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and the EMA (European Medicines Agency). For a medicinal product to be available on the market it needs to have a marketing authorisation. The marketing authorisation application (MAA) must provide evidence of the efficacy, safety and quality of the medicine. When applying for a marketing authorisation for a medicine, the marketing authorisation application is submitted to a regulatory authority, which will assess the medicinal product’s pharmaceutical and chemical quality, efficacy and safety, as well as its risk-benefit ratio.
Have you successfully developed a drug product in a prefilled syringe and are now wondering how to get it on the European market?<br />According to the European Union Regulation (EU) 2017/745 (MDR) Article 1(9), a prefilled syringe (PFS) is identified as “a single integral product which is intended exclusively for use in the given combination, and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable” (1). According to 2017/745 Article 1(9), you must prove that the device part of your combination product complies with the appropriate General Safety and Performance Requirements (GSPRs) laid out in Annex I of MDR. As you can no longer do a self-assessment, you will need to reach out to one of the currently designated 43 Notified Bodies in Europe (2) to do the conformity assessment for you. The results of the assessment are then captured in the Notified Body Opinion (NBOp) which you are required to include in the submission file to EMA or your national competent authority.
The recent Pharmapack meeting in Paris provided a great global overview of the latest in pharmaceutical packaging and delivery. This meeting involved not only the traditional tradeshow, but presentations from pharmaceutical and biotechnology companies as well as from companies offering packaging and delivery systems.
English
Chinese
