The EU Commission proposal for the revision of the Variations Regulation
NCF International
by Manuele Cantù
1w ago
The Commission published its proposal for the revision of the Variation regulation for medicines, as a part of the EU’s Pharmaceutical Strategy for Europe. The final objective is to adapt the current system for variations to the evolving reference framework, to make it more efficient, reduce administrative burdens and better respond to scientific and technological advances. MAHs are responsible for ensuring that each medicine remains compliant throughout its lifecycle.  Variations to the initial authorisation can refer to administrative details, such as a change in company address ..read more
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Unitary SPC, the EU Parliament approved its position
NCF International
by Manuele Cantù
2w ago
The European Parliament adopted on 28 February 2024 in first reading its position about Unitary supplementary certificates (SPCs) for medicinal products and pesticides. The final phase of negotiations with the European Council, representing member states, should occur after the June elections, according to the Parliament. The Unitary SPC should add 5 years to the protection conferred by the original patent, complementing the Unitary patent system. Protection would cover all countries part of the European patent system. Applications for the unitary SPCs should be submitted at the European Uni ..read more
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New partners for Darwin EU
NCF International
by Giuliana Miglierini
3w ago
The Data Analysis and Real World Interrogation Network DARWIN EU has reached twenty partners (public or private institutions) from 13 European countries. The Network aims to generate real-world evidence (RWE) from sources such as hospitals, primary care, health insurance, registries and biobanks to support regulatory activities of EMA’s scientific committees and national regulators in the EU. The current capacity of the DARWIN EU network refers to data from approx. 140 million patients across Europe, which are converted into a common data model. Data are stored and analysed locally to ensure ..read more
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EuropaBio’s data on international biomanufacturing 
NCF International
by Giuliana Miglierini
1M ago
Data presented by EuropaBio highlight the status of the biotech and biomanufacturing sector in relevant competitor countries (i.e. the US, China, India and Japan). The US has a higher number of biotech companies compared to Europe (8,000 vs 4,500), and a  much greater access to funding (3,557 vs 1,558 companies receiving funding between 2015 and 2021). Targets to five years include the expansion of biomanufacturing capabilities to produce at least the 25% of APIs for small molecule drugs needed in the US. The improved economic prosperity and health consciousness of the Indian population ..read more
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The industrial requests of a stronger Single Market
NCF International
by Manuele Cantù
1M ago
EFPIA is among the twenty-six industry associations that have signed a document calling on the European Commission to deepen the EU Single Market. A target deemed fundamental in order to better face competition from countries such as the US and China. According to the document, current actions focused on mapping strategic dependencies, anticipating vulnerabilities, beefing up autonomy, and de-risking should be balanced with the promotion of a frictionless trade within the EU. The goal should be addressed by the systematic enforcement of Single Market rules and the full harmonisation of the r ..read more
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UK, how the pharmaceutical industry can help HPs with complex prescribing decisions 
NCF International
by Manuele Cantù
1M ago
The new guide launched by the Association of the British Pharmaceutical Industry (ABPI) highlights the role the pharmaceutical industry plays in setting out the information aimed to provide high-quality healthcare and supporting clinicians dealing with challenging prescribing decisions. According to the guide, resources from the pharmaceutical industry available to help guide appropriate prescribing include the Summary of Product Characteristics (SmPC), medical information and pharmacovigilance expertise, and medical advisers who can provide information and data as needed, including when it ..read more
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EU Council approved the conclusions on the EU Global Health Strategy
NCF International
by Manuele Cantù
1M ago
The fact that physical and mental health is a human right and that health is a prerequisite for sustainable development are among the conclusions on the ‘EU Global Health Strategy: Better health for all in a changing world’ approved on 29 January 2024 by the European Council. The document reaffirms the leading role of the EU and member states in advancing global health: an effort that would require multilateralism and inclusive multistakeholder partnerships. The Council identified three complementary priorities of the EU Global Health Strategy: deliver better health and well-being for p ..read more
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Concerns on the Munich District Court decisions on SPC
NCF International
by Manuele Cantù
1M ago
The first judgement on the Supplementary Protection Certificate (SPC) manufacturing waiver issued by the Munich District Court, Germany in October 2023 caused a deep concern among the generic and biosimilar industry, as highlighted in a note from Medicines for Europe. According to the industrial representative, the Munich District Court would have adopted an inordinately restrictive interpretation of the SPC manufacturing waiver, which contradicts the purpose and spirit behind the amendments introduced until its final approval. “This utterly frustrates the aims of the legislation and disince ..read more
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The creation of the African Medicines Agency
NCF International
by Manuele Cantù
1M ago
A €10 million grant from the European Commission will allow the European Medicines Agency to provide support to the establishment of the African Medicines Agency (AMA), in collaboration with African, European and international actors. The agreement signed between the EU Commission’s Directorate-General for International Partnerships and EMA marked the official launch of the project. AMA will act as the specialised agency of the African Union (AU) for the regulation and oversight of key medicinal products in Africa. The treaty establishing AMA has already been signed by 27 African c ..read more
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EMA-HMA and MHRA plans on artificial intelligence
NCF International
by Manuele Cantù
1M ago
The role of artificial intelligence (AI) is rapidly expanding in the regulatory field, as acknowledged by the new plans published by EMA and the Heads of Medicines Agencies (HMAs) and UK’s Medicines and Healthcare products Regulatory Agency (MHRA). In the EU, the AI workplan to 2028 prepared under the joint HMA-EMA Big Data Steering Group will support the European medicines regulatory network (EMRN) in the use of AI for personal productivity, automating processes and systems, increasing insights into data and supporting more robust decision-making. At the level of guidance, the public c ..read more
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