EU Commission’s proposal amending the transition period of the MRD regulation
Pharma World Magazine
by Manuele Cantù
5d ago
The very strict timing to reach compliance to the new requirements established by regulation  (EU) 2017/745 (MDR), with the transition period ending 26 May 2024, poses many challenges to manufacturers of medical devices called to obtain a new certification for their products. The concrete risk is that many devices may be discontinued, thus leaving patients and healthcare professionals without the tools needed to treat many health conditions. To answer this urgent issue, the European Commission published on 6 January 2023 a proposal amending article 120(3) of the MDR regulation, so to ex ..read more
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Green light to the new corporate sustainability reporting directive (CSRD)
Pharma World Magazine
by Manuele Cantù
2w ago
The Corporate sustainability reporting directive (CSRD) reached final approval by the European Council in November 2022. After publication in the EU’s Official Journal, the new directive shall be adopted by member states with 18 months. The CSRD strengthens the existing rules on non-financial reporting, and requires companies to publish detailed information on the sustainability of their business. Four different application dates will apply, according to the specific characteristic of each interested company: reporting in 2025 (on financial year 2024) for companies already subject to t ..read more
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Unified Patent Court, the roadmap towards activation
Pharma World Magazine
by Manuele Cantù
3w ago
The new Unified Patent Court is proceeding with the implementation of activities to prepare to the entry into force of the UPC Agreement, currently planned for 1 April 2023. Starting from this date, the Court will begin to receive cases. A total of of 85 judges (34 legally qualified judges and 51 technically qualified judges) have been appointed so far, and shall take up their duties by the same date. UPC’s website is online since 7 November 2022, a unique point of reference where to find all the information on the Court and its activities. A roadmap towards activation is also available ..read more
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The Access Consortium to rely more on GMP inspections of its members
Pharma World Magazine
by Manuele Cantù
1M ago
The Access Consortium – founded in 2007 by regulatory authorities from Australia, Canada, Singapore, Switzerland, and recently joined also by UK’s MHRA – published a Statement to affirm the reliance of its members on GMP inspections carried out by other members of the consortium. The final goal is to mutually accept the results of inspections, so to avoid duplication of efforts. Inspections reports and other documentary evidence for GMP inspections conducted by members within their territory will be reviewed by other members to assess their reliability, even if the statement is not intend to ..read more
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Priorities and actions for the 2023 EU4Health Work Programme
Pharma World Magazine
by Manuele Cantù
1M ago
The Commission Implementing Decision on the financing of the 2023 EU4Health Programme allocates a total budget of €735.8 million to fund the activities listed in Annex 1, according to the established priorities and actions. Total allocation for grants amounts to €428.3 million; €176.4 million will fund procurement (both under direct management), and €131.1 million will be under indirect management. The four countries members of the European Free Trade Association (EFTA; Iceland, Liechtenstein, Norway, and Switzerland) will contribute to the programme with approx. €20.7 million. The budget av ..read more
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HAZEL® GATEWAY GW-MB1: simplify the validation of recovery times in airlocks
Pharma World Magazine
by Redazione
2y ago
The new Annex 1 adopts the Quality Risk Management method to guarantee prevention from the microbic, particulate and biological contamination. This model calls for the adoption of a Contamination Control Strategy, which takes into consideration from a systemic perspective all the critical components of the production cycle. In particular, Section 4.16 mentions the concepts of Design Control Strategy linked to the control of overpressures according to justified and validated strategies. The theme of recovery times In this regard, the possibility of managing and validating the “recovery times ..read more
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EIPG: Upcoming events and a call for consultation
Pharma World Magazine
by Giuliana Miglierini
2y ago
This content is password protected. To view it please enter your password below: Password: L'articolo EIPG: Upcoming events and a call for consultation sembra essere il primo su Pharma World ..read more
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The economic footprint of the biotechnology industry in Europe: Focus in Pharma
Pharma World Magazine
by Giuliana Miglierini
2y ago
This content is password protected. To view it please enter your password below: Password: L'articolo The economic footprint of the biotechnology industry in Europe: Focus in Pharma sembra essere il primo su Pharma World ..read more
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Comments to the public consultation on the new HERA agency
Pharma World Magazine
by Giuliana Miglierini
2y ago
This content is password protected. To view it please enter your password below: Password: L'articolo sembra essere il primo su Pharma World ..read more
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Structured dialogue with the EU Commission to prevent shortages
Pharma World Magazine
by Giuliana Miglierini
2y ago
This content is password protected. To view it please enter your password below: Password: L'articolo Structured dialogue with the EU Commission to prevent shortages sembra essere il primo su Pharma World ..read more
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