EMAMedicines for use outside the EU *— EU-M4all
Promoting the development of medicines and vaccines for patients in low- andmiddle-income countries outside the European Union (EU)How does it work?

What are the benefits?
EU-M4all combines EMA’s scientific review capabilities withthe epidemiology and disease expertise of WHO, experts
and national regulators in the target countries, to promote
the development of high-priority medicines.

• EMA assesses innovative or generic medicines andvaccines that address unmet medical needs or areof major public health interest, for use outside the EU;• EMA evaluates the medicine in collaboration with theWorld Health Organization (WHO) and the relevant
non-EU authorities, in the context of its use in thetarget population;• Experts carry out a robust scientific evaluation andthe medicines are required to meet the same highstandards as medicines marketed in the EU;• National regulators take the decision on whether
or not to use the medicine or vaccine in their country.

The goal is to facilitate the granting of a national
marketing authorisation or the registration of a medicine
at national or regional level.
Regulators, experts and observers from low- andmiddle-income countries are invited to participate in thescientific review. This helps to ensure that specificdisease expertise and local knowledge are taken
into account.
Regulators from target countries can decide on the useof the medicines based on EMA’s scientific assessment.

EU-M4all medicines benefit from the full EMA
regulatory toolkit including scientific advice,
EMA’s PRIME (PRIority MEdicines) scheme andaccelerated review.

The process — step by stepThe sponsor (a pharmaceutical company, a non-governmental organisation (NGO) or academia) should
engage with EMA early for scientific advice (with the involvement of WHO and national regulators)?

The sponsor requests eligibility for EU-M4all

The sponsor submits an application for scientific review to EMA
The assessment is carried out by EMA's Committee for Medicinal Products for
Human Use (CHMP), in collaboration with WHO, experts and national regulators

EMA adopts a scientific opinion, which is published on its website

After the opinion, sponsors are required to implement
risk management plans, just as for medicines approved formarketing in the EU*Article 58 of Regulation (EC) No 726/2004

EMA can perform a benefit-risk review at any time if newsafety data becomes available

EU-M4all — interesting facts
Throughout the evaluation, experts and regulatorsfrom target countries are invited to actively participate inor observe the process.

NGOs and private/public partnerships play an importantrole in the development of medicines to prevent or treat
public health priority diseases.

The EU-M4all procedure is open to innovative newtherapies, new chemical and biological medicines,
including biosimilars, vaccines and generic medicines.

Many medicines are developed by pharmaceuticalcompanies working together with NGOs and academia,
or by NGOs working through product development
partnerships.

13890

approvals have been granted worldwide
based on eleven scientific opinions
through the EU-M4all procedure*

non-EU countries have authorised
medicines evaluated throughthe EU-M4all procedure*

Non-EU countries in which EU-M4all medicines/vaccines have been authorised

Maternal and infant health

Malaria

Umbiproto treat umbilical cord infection
in newborn babies
Hemoprostol
to treat post-partum haemorrhage

Mosquirix
a malaria vaccine for children
Pyramax
to treat malariaChildhood diseases

HIV infection

Hexaxim
Tritanrix HB
combination vaccines forchildhood diseases including
diphtheria, tetanus, pertussis(whooping cough), hepatitis B
and polio

AluviaLamivudine ViiV
Lamivudine / Zidovudine ViiV
to treat HIV infection
Dapivirine Vaginal Ringfor prophylaxis against HIV infection
Sleeping sickness

Medicine has been centrally authorised in the EU*as of July 2020

Fexinidazole Winthrop
to treat human African trypanosomiasis