In the European Union, a new medicine can only be sold once it has demonstrated three things: quality, safety and efficacy. The evidence comes from controlled clinical trials, independently assessed by experts at the European Medicines Agency and national authorities. After reaching the market, a medicine continues to be monitored through pharmacovigilance and can be restricted or withdrawn if new risks appear.
Understanding this system helps Vietnamese people living, studying or travelling in Europe use medicines more safely, and it illustrates an evidence-based approach that health systems in many places are moving towards.
Lessons from past tragedies
Europe’s modern medicines regulation was shaped partly by painful lessons. In the late 1950s and early 1960s, a sedative prescribed to pregnant women caused birth defects in thousands of children across many countries. That tragedy pushed governments to tighten testing before approval and monitoring after sale.
Since then, the guiding principle has been that a medicine must prove it is safe and effective, rather than society having to prove it is harmful.
What the European Medicines Agency does
The European Medicines Agency, EMA, is based in Amsterdam. It is not a giant laboratory testing every pill itself; instead it coordinates a network of thousands of experts from national medicines agencies.
- Scientific assessment of applications through the centralised procedure, which is mandatory for some categories such as biological medicines, cancer treatments and medicines for rare diseases.
- Safety monitoring of medicines across the EU after approval.
- Scientific advice to companies developing medicines.
- Public information on assessments, so doctors and the public can read why a medicine was approved.
The legally binding decision for centrally authorised medicines is issued by the European Commission, based on EMA’s scientific opinion. Many other medicines are still authorised nationally.
Clinical trials: careful step by step
Before reaching patients, a medicine usually goes through several stages. Laboratory and animal studies come first, under strict rules. Then come trials in people:
- Early phase: a small group of participants, focusing on safety and how the body handles the drug.
- Middle phase: a larger group of patients, giving a first look at efficacy and dosage.
- Large phase: hundreds or thousands of patients, compared with standard treatment or placebo, often randomised and blinded.
- After approval: further studies in large populations to detect rare side effects.
In the EU, clinical trials are governed by a common regulation, with a portal that allows a single submission for several countries and public information about trials.
Ethics first, science second
No trial can begin without approval from an ethics committee and the regulator. Participants must be told in plain language about the purpose, risks and benefits, and must give voluntary consent. They can withdraw at any time without explanation and without affecting their normal care. Vulnerable groups such as children or people unable to decide for themselves have special protections.
Putting participants’ dignity above the speed of research is something worth learning from.
Pharmacovigilance: constant watchfulness
Even large trials cannot detect every rare side effect. That is why Europe maintains a pharmacovigilance system: doctors, pharmacists and patients themselves can report suspected side effects. Reports are pooled in a shared database and analysed for signals. When concerns arise, a committee dedicated to risk assessment can recommend updating the leaflet, restricting use or withdrawing a medicine.
Some new medicines carry a black inverted triangle on their leaflet, meaning they are under additional monitoring and all side effects should be reported.
Reading a European medicine leaflet
Every medicine sold in the EU comes with a leaflet written for patients, not only for doctors. It follows a standard order: what the medicine is for, what to know before taking it, how to take it, possible side effects, how to store it and what it contains. Once you know this structure, even a leaflet in an unfamiliar language becomes easier to navigate with a translation app.
Generics and biosimilars
When patents expire, other companies can make generic medicines with the same active substance and quality, usually at lower prices. For complex biological medicines, similar versions called biosimilars must prove comparability through rigorous assessment. Europe was among the first to build a regulatory framework for biosimilars, helping many patients access expensive treatments at lower cost.
What Vietnamese people in Europe should know
- Prescription medicines require a doctor’s prescription. Many antibiotics, sleeping pills and strong drugs that are easy to buy in Vietnam need a prescription in Europe.
- Pharmacists are a reliable source of advice for minor illnesses; do not hesitate to ask.
- Leaflets are in the local language; use a translation tool if needed, but ask a pharmacist when unsure.
- Bringing medicines from home: check customs rules, carry your prescription and keep medicines in original packaging.
- Traditional remedies and supplements have separate rules, and some ingredients may be restricted.
- Buying online: use only legitimate pharmacies; the EU has a common logo to identify authorised online pharmacies.
Seeing a doctor before the pharmacy
In many European countries the usual path for anything beyond minor complaints is a general practitioner, who decides whether you need a prescription or a specialist. Appointments may take time, which surprises newcomers used to walking straight into a pharmacy. Registering with a doctor soon after arriving, and knowing the out-of-hours number, saves stress when you actually fall ill.
Transparency and debate
The system is not perfect. There are debates about speed: too slow and patients wait, too fast and risks rise. There are debates about the price of new medicines and each country’s decision on whether to reimburse them. The recent pandemic showed both the capacity for rapid assessment and the pressures of deciding quickly. What stands out is that assessment reports are made public so experts can scrutinise them.
Studying pharmacy and clinical research in Europe
Europe has strong pharmacy and medical schools, biomedical institutes and a large pharmaceutical industry. Vietnamese students interested in pharmacology, clinical research, regulatory affairs or epidemiology can find master’s and doctoral programmes. Check degree, language and professional recognition requirements on each university’s and country’s official websites.
What to remember
Europe’s approach to medicines rests on a simple idea: patients’ trust must be built on evidence, ethics and transparency. From controlled trials to post-marketing surveillance, each step answers one question: do the benefits really outweigh the risks? It is a question every person taking medicine, anywhere, should feel free to ask.
Frequently asked questions
Does the European Medicines Agency make or sell medicines?
No. It provides scientific assessment and safety monitoring; legal authorisation for centrally approved medicines is issued by the European Commission.
Are all medicines in Europe approved by the EMA?
No. Some categories must go through the centralised procedure, while many others are authorised by national agencies or procedures between countries.
How are clinical trial participants protected?
Trials need approval from ethics committees and regulators, participants must be fully informed and give voluntary consent, and they can withdraw at any time.
Can I bring medicines from Vietnam to Europe?
A reasonable personal supply with a prescription is usually allowed, but some medicines are restricted. Check the destination country’s customs rules before travelling.
Can patients report side effects?
Yes. In EU countries patients can report suspected side effects through their national medicines agency.
