english.prescrire.org > Topics > Advancing healthcare policy > EMA: assessing the risks of drugs for human reproduction and lactation (July 2025)

Advancing healthcare policy

Via its policy advocacy, Prescrire acts as a force for change in health policies, first and foremost in the interest of patients.

Advancing healthcare policy

Chronological recap of actions
Actions presented by theme

EMA: assessing the risks of drugs for human reproduction and lactation (July 2025)

Prescrire participated in a consultation on the revision of the "Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation". Learn more...

©Prescrire 1 July 2025

Source: "EMA: assessing the risks of drugs for human reproduction and lactation" Prescrire Int 2025; 34 (272): 194. FREE.

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Proposed multi-stakeholder platform to improve clinical trials in the European Union (December 2023)
Publication of clinical trial protocols (October 2023)
Prescrire: a cosignatory of letters to various European institutions (October 2023)
Prescrire's annual review of drug packaging: progress is too slow (September 2023)
Impending changes to European pharmaceutical regulations: part II (January 2023)
Impending changes to European pharmaceutical regulations: part 1 (December 2022)
The European Implementing Regulation on Pharmacovigilance Activities (September 2022)
Prescrire's annual review of drug packaging: choose high-quality packaging for safer health care (September 2022)
EMA's response to Prescrire's analysis of EMA's transparency policy over the last 10 years (September 2022)
Delays in access to EMA documents: the Agency confers with Prescrire (July 2022)
Prescrire is taking action at the European level (July 2022)
Prescrire's analysis of EMA's transparency policy over the last 10 years: EMA's reply with Prescrire's comments (6/2022)
Prescrire's response to public consultation on the revised Guideline on the acceptability of names for human medicinal products (3/2022)
Prescrire's response to the public consultation on the revision of European pharmaceuticals legislation (12/2021)
Pharmacovigilance activities: the Commission's proposed changes to the 2012 Regulation encourage greater independence, better quality control and disclosure, but further improvements still needed (10/2021)
Revision of the EU's general pharmaceutical legislation in 2022: Prescrire's remarks on the European Commission Roadmap (4/2021)
Prescrire’s response to the European Commission public consultation on the Inception Impact Assessment on a "European Health Emergency Preparedness and Response Authority" (2/2021)
Prescrire’s response to the EC's consultation on the pharmaceutical strategy roadmap (7/2020)
White paper on artificial intelligence: Prescrire's response to the EC's public consultation (6/2020)
Corporate influence on medicines policy and on regulatory decision-making needs more scrutiny (2/2020)
Independent information does exist, but deserves more attention and visibility (2/2020)
Access to clinical study reports: EMA's transparency policy and disclosure of vital documents should not be scaled back (12/2019)
EMA's independence is paramount: concrete alternatives to the fee-for-service system must be found (10/2019)
Drug-device combinations: EMA's consultation on quality requirements is an opportunity to strengthen patient safety (8/2019)
Electronic product information: EMA and competent authorities must guarantee public access to quality information, and uphold the ban on DTCA (7/2019)
Prescrire's response to the EMA Regulatory Science strategy to 2025: refocus on public health mission as gatekeeper and strengthen pharmacovigilance (6/2019)
Orphan drugs: affordability is at risk due to abuse of orphan drug incentives (4/2019)
Patient-centered authorisation and supervision of health products cannot be based on hope and promises: the use of big data needs to rely on facts, trustworthy evidence and transparency (4/2019)
Last chance to safeguard citizens' protections by removing "Innovation Principle" from Horizon Europe (3/2019)
A call for timely application of the new rules on medical devices and complete transparency concerning high-risk medical devices with public access to Eudamed (2/2019)
It is high time to put an end to EMA's opaque and confidential practice of early scientific advice (1/2019)
"Implant Files" : Campaign for an effective marketing authorisation for high-risk medical devices (12/2018)
Health technology assessment: the European Parliament's position improves substantially upon the Commission proposal (10/2018)
Cochrane's sinking ship and conflicts of interest (9/2018)
Public funding is key for the independence of the EMA (7/2018)
Drug prices, therapeutic value and access to medicines: civil society adds its voice to the debate in France, to defend the public interest (6/2018)
Methotrexate: room for improvement in packaging and patient information (5/2018)
Medicines shortages: drug companies have a duty to produce medicines in sufficient quantity and quality (5/2018)
Prescrire's position paper on the proposed European Regulation on health technology assessment (HTA) (3/2018)
Electronic access to EU product information might improve access to updated patient leaflets, but should not open the door to advertising (2/2018)
Horizon 2020: need to improve public return on public investment for EU's investment in research in the area of health (12/2017)
No to EMA's provision of confidential scientific advice to drug companies (11/2017)
French drug agency's recommendations on packaging labelling: a welcome first step, to be optimised (11/2017)
Supplementary protection certificates (SPCs) delay access to affordable medicines (9/2017)
French drug agency's recommendations on dosing devices: a step forward (9/2017 )
Prescrire applauds the work of the European Ombudsman over the past several years (7/2017)
Proposed changes to EMA's access to documents policy fall short on proactive disclosure (5/2017)
Response to the EU Commission consultation on the Paediatric Regulation (2/2017)
Drug therapy and medication safety for older people clearly require more attention (1/2018)
Health technology assessment: joint response to the EU Commission Consultation (1/2017)
Proposed recommendations on drug brand names by France's Health Products Agency maintain dangerous confusion (12/2016)
Antidiabetic drugs: demand clinical endpoints that are useful to patients, and evaluate risks before, not after, MA (10/2016)
Open letter to the EC on "Strengthening the Balance in the Pharmaceutical Systems" (9/2016)
EMA's report on adaptive pathways: little data and much ado about nothing (8/2016)
The need for a critical review of the intellectual property system and incentives for medical innovation (6/2016)
Prescrire's response to EMA consultation on pharmacovigilance and risk management (5/2016)
Member States ought to support the EU Presidency's vision on access to affordable medicines (4/2016)
Trilogue Meetings: increase transparency to level the playing field (3/2016)
Representatives of civil society call for an R&D framework driven by global public health needs (2/2016)
Why You Should Be Concerned About TTIP and Access to Medicines (2/2016)
Joint response to the EMA public consultation on "Scientific guidance on post-authorisation efficacy studies" (1/2016)
A PRIME example of how EMA is pushing for accelerated market approvals, but at what cost for patients? (12/2015)
"Adaptive licensing" or "adaptive pathways": Deregulation under the guise of earlier access (10/2015)
Marketing authorisation flexibilities should only respond to true needs and must protect patients' safety (9/2015)
European medicines agencies must address independence and transparency problems (7/2015)
EU directive on trade secrets: amendments needed! (3/2015)
EU Clinical Trials Regulation: EMA steers away from transparency (2/2015)
European Directive on trade secrets: A threat to access to public health data (2/2015)
Approval of a dangerous amphetamine drug: unacceptable EMA recommendation (12/2014)
EU trade secrets directive: statement by a multi-sectoral NGO coalition (12/2014)
Medicinal products used in weight control: first, do no harm (12/2014)
EMA softens its conflict of interest policy (11/2014)
WHO statement on public disclosure of clinical data: joint response (11/2014)
Medicines are not just a commodity (follow-up) (10/2014)
EMA's final policy on access to clinical data (10/2014)
EU Pharmacovigilance public hearings (10/2014)
Clinical trials regulation: a major advance in transparency (9/2014)
INNs of biologics and biosimilars: consistency must be preserved (9/2014)
Mr Juncker, medicines are not just a commodity... (9/2014)
A step backwards on pharmaceutical policy at the EU Commission (9/2014)
EMA's policy on pharmacovigilance data (9/2014)
Providing "scientific advice" to pharma industry undermines the independence of regulatory authorities (7/2014)
'Investor-to-state dispute settlement' in EU–US trade deal threatens access to affordable medicines (7/2014)
EMA's new policy on access to clinical data (6/2014)
Backpedalling on EMA’s "proactive publication of clinical-data" draft policy (5/2014)
Clinical trial data disclosure policy in the US (4/2014)
The US-EU Trade Agreement Proposals by the pharmaceutical industry undermine European public policy making and public health (3/2014)
EU Regulation on clinical trials: close to the finish line (3/2014)
Is the EMA's window of opportunity as widely open as described? (1/2014)
EU Regulation on clinical trials: The protection of clinical trial participants must not be undermined (12/2013)
EU Regulation on Medical Devices: Patient safety should be of paramount importance (11/2013)
EU Regulation on clinical trials: An urgent call for support to clinical data transparency (11/2013)
"Biosimilars": the EMA makes a timid shift towards a more pragmatic approach (10/2013)
Medical devices: EU parliament missed needed improvements (10/2013)
Transparency in the public interest: How the EMA policy on publication and access to clinical-trial data could help save lives (9/2013)
Confusion between commercial names: EMA more concerned with defending trademarks than patient safety (8/2013)
EU Regulation on clinical trials: the Council must further enhance transparency and participants' protection (7/2013)
The debate over EU Clinical Trials Regulation: towards a model that meets real public health needs (7/2013)
Medical devices: joint communication campaign (7/2013)
Revision of the Helsinki Declaration on Ethical Principles: Prescrire's response (6/2013)
EMA refusing access to administrative documents: Prescrire denounces an unacceptable retrogression (6/2013)
Clinical Trials Regulation (amendment analysis): ignorance = harm! (5/2013)
Medical devices legislation: regaining the trust of European citizens (5/2013)
Amended proposal for a new directive on transparency measures regulating the prices of medicinal products: still threatening Member States' health systems (4/2013)
Clinical trials regulation: choose transparency! (4/2013)
New proposal for a Regulation on clinical trials: Protect human subjects; Strengthen citizens' right to information (2/2013)
Medicinal products used in weight control: first, do no harm!(12/2012)
Is there a need for insulin at 200 units per ml? Why use a new and poorly established analogue? (12/2012)
Safety and usability of packaging and labelling: assessment prior to marketing authorisation for all medicinal products (11/2012)
Who benefits from the European Paediatric Regulation? (11/2012)
Medical devices: an entire overhaul of the medical legislation is needed (10/2012)
French sunshine act: is the French government backing down on industry gifts? (10/2012)
European Medicines Agency and pharmacovigilance: no to a fee-for-service system (9/2012)
Black triangle for medicines: Positive move but poor implementation plan (8/2012)
Proposal for a new Directive on transparency of measures regulating the prices of medicinal products: EC oversteps its role (7/2012)
Access to EU's documents is essential (6/2012)
EU Parliament says no and no again to EMA (5/2012)
Fighting "counterfeit medicines" should not be used as a pretext to track sales data (4/2012)
Amended proposals on "information" to the public: opening the door to advertising of prescription-only medicines (4/2012)
Fingolimod (Gilenya°): EMA's lack of transparency spells danger for patients (2/2012)
Packaging of medicines for paediatric use: Prescrire's response to EMA (12/2011)
Signal detection left to pharmaceutical companies: danger! (11/2011)
Revised proposals on "information" to patients: Still an open door to advertising (10/2011)
Simplified examination of variations? Yes, but first re-evaluate old authorisations (10/2011)
Response to HMA/EMA on identification of commercially confidential information (8/2011)
Packaging for non-prescription medicines: Prescrire's response to EMA (6/2011)
EMA suggestions on comparative clinical trials fall back behind ethical and scientific standards (3/2011)
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2008-2010 Recap
2005-2007 Recap
The 2002-2004 campaign
Final proposals on pharmacovigilance: Some progress, but a missed opportunity (12/2010)
EC puts companies before public health (7/07)
Pharmaceutical Forum's working group: a sham consultation (5/07)
Joint Declaration "Relevant information for citizens" (12/06)
Advanced therapy medicinal products (4/06)
Draft regulation on medicines for paediatric use (7/05)
Medicines for paediatric use: take the time to improve an important project (5/05)
Medicines for paediatric use (1/05)
Conditional marketing authorisation procedure (1/05)
EMA: two surveys about the patient leaflet (december 2024)
New data after marketing authorisation: European Commission consultation (continued) (december 2024)
French Senate hearing on drug shortages (november 2024)
Revision of European pharmaceutical legislation: a disappointing vote in the Parliament (november 2024)
European "pharmaceutical package": letter on clinical data exclusivity (October 2024)
Prescrire's contribution to the EMA's consultation on the "Concept Paper for the Development of a Guideline on Non-Inferiority and Equivalence Comparisons in Clinical Trials" (September 2024)
Prescrire's review of drug packaging in 2023: reconciling ease of use with safety is an ongoing challenge (September 2024)
Conflicts of interest in European health technology assessments (July 2025)
EMA: protecting personal data and commercially confidential information (July 2025)
New data after marketing authorisation: European Commission consultation (July 2024)
Non-comparative trials for marketing authorisations: EMA consultation (July 2024)
EMA: assessing the risks of drugs for human reproduction and lactation (July 2025)
Update to the Declaration of Helsinki (June 2025)
Drug shortages: Prescrire calls for transparency (July 2024)
European Commission public consultation on the revision of European pharmaceutical legislation: Prescrire's response (May 2024)
A "prescription" from French civil society for a new pharmaceutical policy (June 2025)
French Senate resolution on the European "pharmaceutical package" (June 2025)
First version of the European list of critical medicines: Prescrire's comments (April 2024)
Towards DTC advertising for prescription drugs? The autumn will be crucial (continued) (11/2010)
Towards DTC advertising of prescription drugs in Europe? (7/2010)
Revision of European pharmaceutical legislation (February 2024)
Errors related to brand names: the EMA can still do more (march 2025)
EMA's policy on conflict of interest: improvements needed (6/2010)
EMA road map: independence should be the priority (4/2010)
DTC Communication? Europeans deserve better (3/2010)
Medicines placed under the DG-SANCO’s competence (12/09)
EU Commission's proposals endanger the population (10/2009)
Future Commission: need for change in health goods governance (10/09)
EMEA transparency policy falls short: a weak and irresponsible project (9/2009)
EU Commission's proposals on pharmacovigilance dismantle the entire system (6/2009)
Legal proposals on "information" to patients by pharmaceutical companies (3/09)
Pharmaceutical package: a short-sighted vision that puts patients at risk (3/2009)
Joint open letter on the "Pharmaceutical Package" (11/08)
Recast of Medical Devices Directives (7/08)
"Patient information" by pharmaceutical companies: unanimous opposition (6/08)
Pharmacovigilance : overwhelming opposition to the EC proposals (5/2008)
Time to act for Patient Safety (5/08)
EC's "Information" proposal serves firms, not patients (4/08)
New European pharmacovigilance legislation: getting it right (2/08)
EU trade secrets directive: statement by a multi-sectoral NGO coalition (12/2014)

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