Last updated: 23 March 2026
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The European Commission is proposing to revise the EU’s pharmaceutical legislation – the largest reform in over 20 years in order to make it more agile, flexible, and adapted to the needs of citizens and businesses across the EU.
What is the revision of the EU pharmaceutical legislation expected to achieve?
The revision will:
- make medicines more available, accessible and affordable
- support innovation and boost the competitiveness and attractiveness of the EU pharmaceutical industry, while promoting higher environmental standards.
In addition to this reform, the Commission proposes a Council Recommendation to step up the fight against antimicrobial resistance (AMR).
What are the main objectives of the revision of the EU pharmaceutical legislation?
- Create a Single Market for medicines ensuring that all patients across the EU have timely and equitable access to safe, effective, and affordable medicines;
- Continue to offer an attractive and innovation-friendly framework for research, development, and production of medicines in Europe;
- Reduce drastically the administrative burden by speeding up procedures significantly reducing authorisation times for medicines, so they reach patients faster;
- Enhance availability and ensure medicines can always be supplied to patients, regardless of where they live in the EU;
- Address antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment through a One Health approach;
- Make medicines more environmentally sustainable.
Frequently asked questions about the revision of the legislation
A Q&A has been published on the commission website, with information provided under 14 headings. A summary is provided below for 11 out of the 14 headings.
1. What does the package consist of?
The reform includes two legislative proposals which constitute the EU regulatory framework for all medicines (including those for rare diseases and for children). They are:
- a new Directive which contains all the requirements for:
- authorisation
- monitoring
- labelling and regulatory protection
- placing on the market and other regulatory procedures for all medicines authorised at EU and national level.
- a new Regulation which sets:
- specific rules (on top of the ones in the Directive) for medicines authorised at EU level, in particular the most innovative ones.
- out the rules:
- on coordinated management of critical shortages and security of supply of critical medicines.
- governing the European Medicines Agency (EMA).
- The reform also includes a Council Recommendation on antimicrobial resistance (AMR).
Finally, these legislative proposals and Council recommendation are accompanied by a Communication that explains the rationale of the changes
How does the proposal adopted by the commission impact the current legislation?
As already stated above, the proposed revision of the pharmaceutical legislation will consist of two legislative proposals:
- a new directive, repealing and replacing Directive 2001/83/EC and Directive 2009/35/EC of the European Parliament and of the Council and incorporating relevant parts of the Paediatric Regulation (Regulation (EC) No 1901/2006)
- a new regulation, repealing and replacing Regulation (EC) No 726/2004, repealing and replacing the Orphan Regulation (Regulation (EC) No 141/2000) and repealing and incorporating relevant parts of the Paediatric Regulation (EC) No 1901/2006).
The merger of the Orphan Regulation and the Paediatric Regulation with the legislation applicable to all medicinal products will allow for simplification and increased coherence.
2. What is new in this reform?
The reform builds on the current high standards of quality, safety, and efficacy for the authorisation of medicines and proposes various new tools including in the following areas:
- Move away from a “one-size-fits-all” system of incentives for pharmaceutical companies to a modulated system of incentives that rewards companies that fulfil important public health objectives, such as:
- giving access to medicines in all Member States,
- developing medicines that address unmet medical needs,
- conducting comparative clinical trials and developing medicines that can treat other diseases as well
- Faster availability of generics and biosimilars and transparency of public funding
- A modern and simplified regulatory framework with faster authorisations of new medicines.
- For instance, for its assessment, EMA will have 180 instead of 210 days.
- For the authorisation, the Commission will have 46 instead of 67 days. This will help to reduce the current average of around 400 days between submission and market authorisation.
- For the assessment of medicines that are of major public health interest, EMA will only take 150 days regulatory sandboxes supporting the development of innovative medicines, electronic submissions and e-leaflets
3. How will the new legislation promote innovation?
Innovation will be provided in a variety of ways including the following:
- Early scientific advice by EMA will improve the quality of applications and tailored scientific support will be provided to SMEs
- Developers of innovative products will receive advice on their product even years before they actually apply for a marketing authorisation which will facilitate their decisions.
- The regulatory framework will be more agile to accommodate scientific advances, digitalisation, artificial intelligence and cutting-edge products
- Companies marketing innovative medicines will have a minimum period of regulatory protection of 8 years, which includes 6 years of data protection and 2 years of market protection. Companies may benefit of additional periods of protection, increasing the total period up to maximum 12 years, while it is maximum 11 years today. These additional periods of protection can be obtained if the companies launch the medicine in all Member States (+2 years), if the medicine addresses an unmet medical need (+6 months), or if comparative clinical trials are conducted (+6 months). A further year of data protection can be granted if the medicine can treat other disease(s) too.
- For medicines for rare diseases, the standard duration of market exclusivity will be 9 years. Companies can benefit from additional periods of market exclusivity if they address a high unmet medical need (1 year), launch the medicine in all Member States (+ 1 year), or develop new therapeutic indications for an already authorised orphan medicine (up to 2 extra years). The regulatory production periods can add up to maximum 13 years while today the maximum is 10 years.
4. Will the proposed reform have an impact on the Intellectual Property (IP) protection covering medicinal products?
No it will not have any impact on the Intellectual Property (IP) protection covering medicinal products?
5. What is the AMR “vouchers” system about?
It will provide ‘transferable data exclusivity vouchers’ to developers of ‘game changing’ novel antimicrobials, which they can either use themselves or sell.
The voucher will offer to the developer an additional year of data protection from competition for the medicine that the voucher applies to.
6. How will the new rules give patients access to more and innovative medicines?
- A central objective of the reform is to ensure that all patients across the EU have timely and equitable access to safe and effective medicines.
- The reform addresses this concern by making two years of data protection conditional on launching a medicine in all Member States.
- A reduction of the standard regulatory protection period by 2 years (compared to today) and measures that encourage early market access of generic and biosimilar entry will also provide more affordable options to patients and contain health systems’ pharmaceutical expenditure.
- Incentives for repurposing existing medicines and for using comparative trial data will give patients quicker access to new therapies that deliver on their needs. Using comparative trial data will help national authorities to better assess the cost effectiveness of a new medicine.
- A simplified decision-making system reduces authorisation times for new medicines
- Incentives will be offered for the development of innovative medicines addressing unmet medical needs.
- In addition to the existing paper leaflets, electronic product information will ensure accurate information to patients in their own language through electronic leaflets and help address shortages through the easier redirection of stocks to countries that need them.
7. Will the new rules impact the way medicines and vaccines are authorised in the EU?
Yes they will, by reducing the regulatory burden, with a leaner EMA structure. They will simplify procedures to:
- ensure efficient assessments,
- boost the scientific capacity of the EU regulatory network and
- reduce the time for authorisation of medicines
The voice of patients will be strengthened by adding patient representatives to the main scientific committee of the EMA.
8. How will changes to EMA’s work speed up the authorisation of medicines?
The legal proposal simplifies EMA’s structure to two main scientific committees for human medicines:
- the Committee for Human medicinal products and
- the Safety Committee (PRAC).
The orphan, paediatric and ATMP committees would be discontinued.
The mandate of the EMA and its Executive Steering Group on Shortages and Safety of Medicinal Products will be extended with respect to the management of critical shortages and the security of supply of critical medicines
An inspectorate will be established within EMA to reinforce Member States’ capacities, in particular for inspections in third countries to build efficiency in surveillance and support marketing authorisation procedures.
9. Will there be more transparency on the development of medicines?
Yes, there will be greater transparency on public support for the development of medicines which may strengthen the negotiating position of authorities responsible for pricing and reimbursement of medicines when negotiating prices with the pharmaceutical companies which may in turn help reduce prices and thereby improve access to medicines.
Pharmaceutical companies will be required to publish information on all direct financial support for the R&D of medicines received from public authorities or publicly funded bodies. This information will be easily accessible to the public on a dedicated webpage of the company and through the database of medicinal products for human use authorised in the Union.
10. Will the reform tackle shortages of medicines?
Yes it will.
The extension of EMA’s mandate as part of the European Health Union, allowed improving coordination and management of the supply of medicines shortages during crises.
The new legislation will enhance the monitoring and mitigation of medicines shortages, in particular critical shortages, at national level and by EMA.
Pharmaceutical companies will have to:
- report shortages of medicines more quickly and establish shortage prevention plans.
- address critical shortages, and report on the results of the measures taken (such as the increase or reorganisation of manufacturing capacity or the adjustment of distribution to improve supply).
In addition, an EU list of critical medicines – i.e. medicines considered to be most critical for health systems at all times – will be established.
The legislation will also allow the Commission to introduce, through an implementing act, measures to strengthen security of supply, including requirements to establish contingency stocks.
14. Impact of extending the duration of regulatory data protection in the new EU pharmaceutical legislation
Medicines for Europe has published a document which provides an economic analysis of the extension of regulatory data protection periods proposed in the European Parliament, which have strong political support. You can view it here.
Table mapping of some of the main Articles of Directive 2001/83/EC to the proposed new Directive
Using the mapping table below, you can compare the text in some of the main Articles of Directive 2001/83/EC with the text in the Articles of the proposed Directive.
Table 1
| Current | Proposed |
|---|---|
| Consolidated Directive 2001/83/EC | 24 February 2026 (ST-6367-2026-INIT) (Proposed Directive) |
| TITLE III PLACING ON THE MARKET CHAPTER 1 Marketing authorization | Chapter II Application requirements for national and centralised marketing authorisations |
| Article 8 | Article 6 – General requirements for marketing authorisation applications |
| Article 12 | Article 7 Expert verification of detailed summaries |
| SECTION 2 SPECIFIC REQUIREMENTS FOR ABRIDGED, BIBLIOGRAPHIC OR CONSENT BASED APPLICATIONS FOR MARKETING AUTHORISATION | |
| Article 10 1. By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 6 for not less than eight years in a Member State or in the Community. A generic medicinal product authorised pursuant to this provision shall not be placed on the market until ten years have elapsed from the initial authorisation of the reference product. The first subparagraph shall also apply if the reference medicinal product was not authorised in the Member State in which the application for the generic medicinal product is submitted. In this case, the applicant shall indicate in the application form the name of the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the application is submitted, the competent authority of the other Member State shall transmit within a period of one month, a confirmation that the reference medicinal product is or has been authorised together with the full composition of the reference product and if necessary other relevant documentation. The ten-year period referred to in the second subparagraph shall be extended to a maximum of eleven years if, during the first eight years of those ten years, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies. 2. For the purposes of this Article: (a) ‘reference medicinal product’ shall mean a medicinal product authorised under Article 6, in accordance with the provisions of Article 8; (b) ‘generic medicinal product’ shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information providing proof of the safety and/or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant. The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. Bioavailability studies need not be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines. ………………………….etc. | Article 9 Applications concerning generic medicinal products 1. By way of derogation from Article 6(2), the applicant for a marketing authorisation for a generic medicinal product shall not be required to provide to the competent authorities the results of non-clinical tests and of clinical studies if equivalence of the generic medicinal product with the reference medicinal product is demonstrated. 2. For the purpose of demonstrating the equivalence as referred to in paragraph 1, the applicant shall submit to the competent authorities equivalence studies, or a justification as to why such studies were not performed, and demonstrate that the generic medicinal product meets the relevant criteria set out in the appropriate detailed guidelines 3. Paragraph 1 shall also apply if the reference medicinal product has not been authorised in the Member State in which the application for the generic medicinal product is submitted. In this case, the applicant shall indicate in the application the name of the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the application is submitted, the competent authority of the other Member State shall transmit within a period of one month a confirmation that the reference medicinal product is or has been authorised together with the full composition of the reference medicinal product and if necessary, any other relevant documentation. The various immediate-release oral pharmaceutical forms shall be considered to be the same pharmaceutical form. 4. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety or efficacy. In those cases, the applicant shall submit additional information to demonstrate that the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance do not differ significantly in respect of those properties. 5. Where there is a significant difference in properties as referred to in paragraph 4, the applicant shall submit additional information in order to prove the safety or efficacy of the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of the authorised active substance of the reference medicinal product in an application under Article 10. |
| Article 10(3) 3. In cases where the medicinal product does not fall within the definition of a generic medicinal product as provided in paragraph 2(b) or where the bioequivalence cannot be demonstrated through bioavailability studies or in case of changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration, vis-à-vis the reference medicinal product, the results of the appropriate pre-clinical tests or clinical trials shall be provided. | Article 10 Applications concerning hybrid medicinal products In cases where the medicinal product does not fall within the definition of a generic medicinal product or has changes in strength, pharmaceutical form, route of administration or therapeutic indications, compared to the reference medicinal product, the results of the appropriate non-clinical tests or clinical studies shall be provided to the competent authorities to the extent necessary to establish a scientific bridge to the data relied upon in the marketing authorisation for the reference medicinal product, and to demonstrate the safety and efficacy profile of the hybrid medicinal product. |
| Article 10(4) 4. Where a biological medicinal product which is similar to a reference biological product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or differences in manufacturing processes of the biological medicinal product and the reference biological medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in Annex I and the related detailed guidelines. The results of other tests and trials from the reference medicinal product’s dossier shall not be provided. | Article 11 Applications concerning biosimilar medicinal products For a biological medicinal product that is similar to a reference biological medicinal product (‘biosimilar medicinal product’), the results of appropriate comparability tests and studies shall be provided to the competent authorities. The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in Annex II and the related detailed guidelines. The results of other tests and studies from the reference medicinal product’s dossier shall not be provided. |
| Article 12 Applications concerning bio-hybrid medicinal products In cases where the biological medicinal product does not fall within the definition of a biosimilar medicinal product or has changes in strength, pharmaceutical form, route of administration or therapeutic indications, compared to the reference biological medicinal product (‘bio-hybrid’), the results of the appropriate non-clinical tests or clinical studies shall be provided to the competent authorities to the extent necessary to establish a scientific bridge to the data relied upon in the marketing authorisation for the reference biological medicinal product, and to demonstrate the safety orand efficacy profile of the bio-hybrid medicinal product. | |
| Article 10a By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests or clinical trials if he can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Community for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex I. In that event, the test and trial results shall be replaced by appropriate scientific literature. | Article 13 Applications based on bibliographic data The applicant shall, by way of derogation from Article 6(2), not be required to provide the results of non-clinical tests or clinical studies if the applicant can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Union for the same therapeutic use and route of administration and for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex II. In that event, the test and trial results shall be replaced by appropriate bibliographic data in the form of scientific literature, and the applicant shall establish a scientific bridge between the bibliographic data and the medicinal product concerned. An application based on this Article may only be submitted if the applicant can demonstrate that: (a) no reference medicinal product is or has been authorised in the Union for the active substance of the medicinal product concerned at the time of submission of the marketing authorisation application; or (b) while a reference medicinal product for the active substance of the medicinal product concerned has been authorised, it is not available on the market within the Union; or (c) the application concerns a herbal medicinal product for which efficacy and safety have been established and documented in a relevant Union herbal monograph. |
| Article 10c Following the granting of a marketing authorisation, the authorisation holder may allow use to be made of the pharmaceutical, pre-clinical and clinical documentation contained in the file on the medicinal product, with a view to examining subsequent applications relating to other medicinal products possessing the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form. | Article 14 Applications based on consent Following the granting of a marketing authorisation, the marketing authorisation holder may, by letter of access, allow use to be made of all documentation referred to in Article 6(2) for the purpose of examining subsequent applications relating to other medicinal products possessing the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form. |
| SECTION 3 SPECIFIC REQUIREMENTS FOR APPLICATIONS FOR CERTAIN CATEGORIES OF MEDICINAL PRODUCTS | |
| Article 15 Fixed dose combination medicinal product, platform marketing authorisation and multi-medicinal product packages 1. Where justified for clinical purposes, a marketing authorisation may be granted for a fixed dose combination medicinal product. 2. Where justified for clinical purposes, a marketing authorisation may be granted for a medicinal product comprised of a fixed component and a variable component that is pre-defined in order to, where appropriate, target different variants of an infectious agent or, where necessary, to tailor the medicinal product to characteristics of an individual patient or a group of patients (‘platform marketing authorisation’). An applicant that intends to submit an application for a marketing authorisation for such a medicinal product shall seek, in advance, the agreement concerning the submission of such application by the competent authority concerned. 3. Where justified for public health reasons and when the active substances cannot be combined within a fixed dose combination medicinal product, a marketing authorisation may, in exceptional circumstances, be granted to a multi-medicinal product package. An applicant that intends to submit a an application for a marketing authorisation for such a medicinal product shall seek, in advance, the agreement concerning the submission of such application by the competent authority concerned. | |
| Article 18 Integral combinations of medicinal products and medical devices | |
| Article 19 Medicinal products in exclusive use with medical devices or in-vitro diagnostic medical devices | |
| Article 20 Combinations of medicinal products with products other than medical devices | |
| Chapter V Article 56a Specific requirements on making available and supplying of a medicinal product in a Member State | |
| TITLE V LABELLING AND PACKAGE LEAFLET | Chapter VI Product information and labelling |
| Article 54 The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging: (a) the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults; where the product contains up to three active substances, the international non-proprietary name (INN) shall be included, or, if one does not exist, the common name; (b) a statement of the active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names; (c) the pharmaceutical form and the contents by weight, by volume or by number of doses of the product; (d) a list of those excipients known to have a recognized action or effect and included in the detailed guidance◄ published pursuant to Article 65. However, if the product is injectable, or a topical or eye preparation, all excipients must be stated; (e) the method of administration and, if necessary, the route of administration. Space shall be provided for the prescribed dose to be indicated; (f) a special warning that the medicinal product must be stored out of the reach and sight of children; (g) a special warning, if this is necessary for the medicinal product; (h) the expiry date in clear terms (month/year); (i) special storage precautions, if any; (j) specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, where appropriate, as well as reference to any appropriate collection system in place; (k) the name and address of the marketing authorisation holder and, where applicable, the name of the representative appointed by the holder to represent him; (l) the number of the authorization for placing the medicinal product on the market; (m) the manufacturer’s batch number; (n) in the case of non-prescription medicinal products, instructions for use; (o) for medicinal products other than radiopharmaceuticals referred to in Article 54a(1), safety features enabling wholesale distributors and persons authorised or entitled to supply medicinal products to the public to: — verify the authenticity of the medicinal product, and — identify individual packs, as well as a device allowing verification of whether the outer packaging has been tampered with. | Article 65 Labelling particulars of the outer or immediate packaging The outer packaging of medicinal products or, where there is no outer packaging, the immediate packaging, with the exception of the packaging referred to in Article 66, paragraphs 2 and 3, shall include the labelling particulars listed in Annex IV. The Commission is empowered to adopt delegated acts in accordance with Article 215 to: (a) amend the list of labelling particulars set out in Annex IV in order to take account of scientific progress or patient needs; (b) supplement Annex IV by setting out a reduced list of mandatory labelling particulars that shall appear on the outer packaging of multi-language multi-country packages that are also multi-lingual. |
Article 55 1. The particulars laid down in Article 54 shall appear on immediate packagings other than those referred to in paragraphs 2 and 3. 2. The following particulars at least shall appear on immediate packagings which take the form of blister packs and are placed in an outer packaging that complies with the requirements laid down in Articles 54 and 62. — the name of the medicinal product as laid down in point (a) of Article 54, — the name of the holder of the authorization for placing the product on the market, — the expiry date, — the batch number. 3. The following particulars at least shall appear on small immediate packaging units on which the particulars laid down in Articles 54 and 62 cannot be displayed: — the name of the medicinal product as laid down in point (a) of Article 54 and, if necessary, the route of administration, — the method of administration, — the expiry date, — the batch number, — the contents by weight, by volume or by unit. | Article 66 Labelling of blister packs or small immediate packaging 1. The particulars laid down in Annex IV shall appear on immediate packagings other than those referred to in the paragraphs 2 and 3. 2. The following particulars at least shall appear on immediate packagings that take the form of blister packs and are placed in an outer packaging that complies with the requirements laid down in Articles 65 and 73. (a) the name of the medicinal product; (b) the name of the marketing authorisation holder placing the product on the market; (c) the expiry date; (d) the batch number. 3. The following particulars at least shall appear on small immediate packaging units on which the particulars laid down in Articles 65 and 73 cannot be displayed: (a) the name of the medicinal product and, if necessary, the route of administration; (b) the method of administration, if not already evident from the name or from the route of administration of the medicinal product, as referred to in point (a); (c) the expiry date; (d) the batch number; (e) the contents by weight, by volume or by unit. |
| Article 56a The name of the medicinal product, as referred to in Article 54, point (a) must also be expressed in Braille format on the packaging. The marketing authorisation holder shall ensure that the package information leaflet is made available on request from patients’ organisations in formats appropriate for the blind and partially-sighted. | Article 71 Accessibility for persons with disabilities The name of the medicinal product, followed by its strength, if appropriate, and pharmaceutical form, if appropriate, shall also be expressed in Braille format on the packaging. The marketing authorisation holder shall ensure that the package leaflet referred to in Article 63 is made available free of charge upon request from patients’ organisations in formats appropriate for persons with disabilities, including blind and partially-sighted persons. |
| Article 57 | Article 72 Member States labelling requirements |
| Article 58 | Article 63 General principles on package leaflet |
| Article 59 | Article 64 Content of package leaflet |
| Article 60 | Article 78 Placing on the market of labelled medicinal products |
| Article 61 | Article 76 Approval of the labelling and package leaflet information |
| Article 62 | Article 73 Symbols and pictogram |
| Annexes The Directive has Two Annexes | Annexes The Directive has Eight Annexes |
| Annex I – Analytical, Pharmacotoxicological and clinical standards and protocols in respect of testing of medicinal products Annex II on Repealed Directives, with their successive amendments | Annexes – Eight annexes Annex I -Information referred to in the application Annex II – Analytical, Pharmacotoxicological and clinical standards and protocols in respect of testing of medicinal products Annex III – Conditions for qualification of a Qualified Person. Annex IV – Labelling particulars – on particulars that shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging Annex V– Contents of Summary of Product Characteristics Annex VI – Contents of package leaflet Annex VII– Areas for adapted frameworks referred to in Article 28 Annex VIII – Correlation Table |
Progress so far
The table below details in brief, the progress so far. Further detailed information is proved after the table.
Table 2
| Date | Event |
|---|---|
| 11 April 2024 | MEPs adopted their proposals to revamp EU pharmaceutical legislation, to foster innovation and enhance the security of supply, accessibility and affordability of medicines. |
| 13 March 2025 | The Official Journal of the European Union published the Parliament’s stance adopted at first reading on the proposed laws (C/2025/1328 and C/2025/1329).6 |
| 4 June 2025 | The Council confirmed that it is ready to begin negotiations with the European Parliament, having agreed its position on new rules that aim to make the EU’s pharmaceutical sector fairer and more competitive. |
| 11 December 2025 | the EMA welcomed political agreement on new EU pharmaceutical legislation reached by the European Commission, the European Parliament and the Council of the European Union on the comprehensive reform of the EU pharmaceutical legislation. |
| 6 March 2026 | The Council of the European Union (“Council”) published the texts of the provisional agreement on new EU pharmaceutical legislation. |
Parliament adopts its position on EU pharmaceutical reform
On 11 April 2024, MEPs adopted their proposals to revamp EU pharmaceutical legislation, to foster innovation and enhance the security of supply, accessibility and affordability of medicines.
The legislative package, covering medicinal products for human use, consists of a new directive (adopted with 495 votes in favour, 57 against and 45 abstentions) and regulation (adopted with 488 votes in favour, 67 against and 34 abstentions)
You can read more about this here or in this blog post.
Source: European Parliament
Official Journal of the European Union published the Parliament’s stance adopted at first reading on the proposed laws
On 13 March 2025, the Official Journal of the European Union published the Parliament’s stance adopted at first reading on the proposed laws (C/2025/1328 and C/2025/1329).6
- These freshly released texts solidify the position adopted on 10 April 2024, but they do not include any new amendments.6
- The EU proposals, which affect key pharma regulatory instruments will continue to navigate through the Union’s legislative process following the ordinary legislative procedure.6
Council confirms readiness for negotiations with the European Parliament
On 4 June 2025, the Council confirmed that it is ready to begin negotiations with the European Parliament, having agreed its position on new rules that aim to make the EU’s pharmaceutical sector fairer and more competitive.
The Council’s mandate for negotiations with the European Parliament introduces several key amendments to the proposed legislation as follows:
| Subject | Proposal |
|---|---|
| Regulatory data protection: | Under the Council’s mandate, companies producing innovative medicines will be able to prevent competitors from accessing the data used to develop those medicines for eight years. |
| Regulatory market protection | In addition, producers of innovative medicines will benefit from one year of regulatory market protection, extendable to two years if certain pre-defined key objectives are achieved. |
| Obligation to supply | A new article (56a) has been added to the directive, giving member states the power to oblige the marketing authorisation holder of a medicinal product to make that product available in sufficient quantities to cover the needs of patients in the member state |
| Transferrable exclusivity voucher: | The Council has introduced a new clause stipulating that a transferred voucher can only be used in the fifth year of the regulatory data protection period, and only if the marketing authorisation holder demonstrates that the annual gross EU sales of the product have not exceeded €490 million in any of the preceding four years |
The Council is now ready to begin negotiations with the European Parliament with a view to reaching an agreement on the package. The new rules will then be adopted following legal-linguistic revision.
Here, you can view the updated versions (2 June 2025) of the proposals for a Regulation and a Directive.
Source: Council of the European Union
It is well worth reading the detail on the amendments in an article by Alexander Roussanov et al on the Bioslice blog as well as an article by Catherine Drew of Pinsent Masons.
Political agreement on new EU pharmaceutical legislation reached by the European Commission, the European Parliament and the Council of the European Union
On 11 December 2025, the EMA welcomed political agreement on new EU pharmaceutical legislation reached by the European Commission, the European Parliament and the Council of the European Union on the comprehensive reform of the EU pharmaceutical legislation.
Key areas affected by the reform
i) A simpler regulatory environment
- Simplified committee structure – EMA will simplify its committee structure from the current five to two scientific committees for human medicines namely:
- the Committee for Human Medicinal Products (CHMP) and
- the Pharmacovigilance Risk Assessment Committee (PRAC).
- Reduced assessment time – The streamlined structure facilitates reduced assessment time (210 to 180 days) and frees up scientific resources to strengthen pre-authorisation support to medicine developers.
- MA valid by default for an unlimited period – The marketing authorisation for a medicine will be valid by default for an unlimited period, avoiding the unnecessary administrative burden linked to renewals unless required on safety grounds by EMA’s scientific committees.
- Digital solutions – The reform will require applicants to submit marketing authorisation applications in electronic and structured formats and to make available approved product information in electronic form (ePI).
ii) More support and improved conditions for innovation
The reform foresees important new elements for public authorities to further support innovation, such as:
- The possibility of extended scientific advice – The possibility for EMA to offer extended scientific advice with HTA bodies or medical device expert panels and strengthened PRIME support.
- The possibility of a regulatory sandbox – The possibility for the European Commission to establish, at the suggestion of EMA and in consultation with Member States, a regulatory sandbox to test, under the direct supervision of the competent authorities, adapted requirements for innovative medicines that cannot be developed under current rules.
- Adapted frameworks – The creation of adapted frameworks for certain non-standard categories of medicines, such as personalised therapies, that can provide a major contribution to patient access or patient care.
- Process efficiency for studying medicines in children– improvements in the efficiency of the process for studying medicines in children, including formalising a new process for iterative paediatric investigation plans (PIPs) already piloted by EMA.
iii) Stronger safeguards against medicine shortages
The reform establishes several new rules for marketing authorisation holders and public health authorities to cooperate to ensure continuity of supply and availability of critical medicines in the EU, including:
- Stronger obligations for companies to ensure continuous supply of medicines.
- The obligation to notify shortages and withdrawals in advance and have shortage prevention plans in place for prescription medicines.
- Monitoring of expected and actual shortages by both EMA and national competent authorities, based on notifications from marketing authorisation holders.
- Establishment of an EU list of critical medicines for which supply chain vulnerability assessments will be carried out.
iv) Enhanced environmental protection and focus on antimicrobial resistance
The reform also introduces strengthened provisions on:
- environmental risk assessment, including special methodologies to evaluate the risk for antimicrobial resistance selection in the environment due to the manufacture of antimicrobials.
- prudent use of antimicrobials, including compulsory medical prescriptions for all antimicrobials, specific information requirements to be provided with the package leaflet, an awareness card and an antimicrobial stewardship plan to be submitted by applicants.
Provisional agreement of the new EU pharmaceutical legislation published
On 6 March 2026 the Council of the European Union (“Council”) published the provisional agreement on new EU pharmaceutical legislation. Here, you can view the new Directive and Regulation. Further information is available in the blog posts at links 11 and 12 in the Further reading section below.
Next steps
The provisional agreement now needs to be endorsed by both the Council of the European Union and the European Parliament, before being formally adopted and entering into force upon publication in the EU’s Official Journal.
- Over the coming months and years, once the text has been formally approved, EMA will work together with the European Commission and EU Member States, to develop relevant guidance for applicants and marketing authorisation holders to comply with the new legal framework.
- To ensure the smooth implementation of the legislation, EMA’s stakeholders will be kept informed and actively involved in the implementation process on specific technical and procedural aspects of the reform.
- EMA plans to publish a new web page that will serve as a gateway and central repository of information on implementation of the new legislation for EMA’s stakeholders.
- The webpage will be updated as implementation work progresses and guidance for pharmaceutical companies becomes available.
Sources: EMA, European Commission
Sources:
1. European Health Union: Commission proposes pharmaceuticals reform for more accessible, affordable and innovative medicines (European Commission) 26 April 2023
2. Reform of the EU pharmaceutical legislation (European Commission) 26 April 2023
Further reading
- Proposed Amendments to the EU Regulatory Framework for Medicinal Products by Jackie Mulryne, Alexander Roussanov, Carla Schoonderbeek, Eleri Williams & Sofia Wilson (April 26, 2023), Bioslice Blog
- EU to link pharma incentives to public health objectives by Catherine Drew and Charlotte Weekes (27 April 2023), Pinsent Masons .
- Pharmavibes blog post, A closer look at some aspects of the proposed revision of the EU pharmaceutical legislation (19 May 2023).
- EMA webinar on revision of the pharmaceutical legislation (16 June 2023)
- Awareness session for SMEs on the revision of the pharmaceutical legislation (24 November 2023), EMA
- As time runs out, the European Parliament remains divided over pharma reform by Martin Greenacre (29 December 2023), sciencebusiness.net
- Council of the European Union backs reforms to the EU Regulatory Framework for Medicinal Products, Alexander Roussanov et al, 6 June 2025, Bioslice blog, Arnold & Porter.
- ‘Pharma package’: Council agrees its position on new rules for a fairer and more competitive EU pharmaceutical sector, 4 June 2025, Council of the European Union.
- EU Pharma Law Package: Council Position on Reduction of Regulatory Exclusivity Rights, Hein van den Bos et al, 10 June 2025, Hogan Lovells.
- The EU pharma package: what we know and what to expect, Xisca Borrás, 19 December 2025, Bristows LLP
- Provisional text of the political agreement on the reform to the EU Regulatory Framework for Medicinal Products is published, Libby Amos et al, 6 March 2026, BioSlice Blog, Arnold & Porter
- The EU Pharma Package Reaches a Milestone: Formal Adoption on the Horizon, Mette-Marie Henrichsen, 17 March 2026, Bird & Bird