How to get a Drug Approved In Europe

The EMA is a European body that is responsible for protecting the public health.

It ensures that there is human safety and security in vaccines, veterinary drugs, medical devices, dietary supplements and biological products.

The EMA ensures that food and drugs of all sorts are checked and administered before they reach the public.

It provides the general public with information to get accurate, science based information about medicines and foods in order to improve their health and also regulates tobacco products.

Being an independent body operating out of the Europe, it is in charge of conducting evaluation of the therapeutic value of new drugs.

The European Drug Approval Process

EMA approval becomes necessary as their approval documents contain rigorously reviewed data submitted by manufacturers in support of new drug approvals.

Gaining the right approvals and certificates for products is extremely vital.

By doing this, the company can ensure appropriateness and safety.

Organizations must make it a point to ensure that they have all the required approvals in place, before launching a product.

Once a drug is synthesized in a lab or purified from a natural source, the next step is typically animal testing.

Common animals used include mice or rats.

This is called the preclinical phase of testing, and if successful an Investigational New Drugapplication is submitted to the European Medicines Agency (EMA).

The IND application is the human trials protocol. The EMA may contest the protocol, but if not after 30 days the manufacturer may start the testing.

Clinical trials are a part of the European Medicines Agency (EMA) process for drug approval.

The intent behind the process is to screen drugs for two things before allowing the public access to the drugs: safety and efficacy.

At each trial stage a drug can ‘fail’ and the research program for it will be terminated or go back to the pretrial stage.

The trial process also gives the EMA data it needs to schedule the drugs if they are approved.

The clinical trials occur in 3 phases.

Phase 1 is giving the drug to healthy volunteers who do not have the disease that will eventually be treated.

This is to check for safety and to determine dosing.

Once completed, Phase 2 consists of giving the drug to patients with the disease also checking for safety and side effects.

The numbers in this phase are small.

Phase one

Phase one may actually have several years’ worth of research invested into the drug before it can begin.

This is because phase one of human testing cannot occur until the company is relatively certain that the drug is both safe for human consumption and stands a reasonable chance of treating the condition it is intended to address.

In a phase one trial, the drug is administered to healthy adults who do not have the condition the drug seeks to treat.

This phase is solely focused on safety.

It creates a draft of possible side effects for the drug, and gives the researchers a base point to tinker with the formula and dosage to minimize the occurrence and severity of side effects.

Phase two

If a drug successfully makes it through the first trial, it will move to phase two.

In phase two, the primary aim is to test the effectiveness of the drug in treating its intended disease or symptom.

A larger group of adults with the proper diagnosis will receive the drug under controlled circumstances to evaluate how well it works, also known as the drug’s efficacy.

Phase three

If the drug is shown to be effective, it will move on to phase three, which tests for drug interactions.

In this phase of the study, the test subject pool is broadened to include patients that have other health problems than the one the drug is intended to treat.

It also includes patients on other medications.

This allows researchers to see how the drug interacts with other medications and conditions before it is released.

Phase 3 is giving the drug to large numbers of patients with the disease so that statistical outcomes can realistically be achieved.

The timeframe for all 3 phases averages 5 years, but can be longer if it is a complex medication or if there are not that many patients with the disease being tested.

After successfully getting through Phase 3, the manufacturer submits a New Drug Application (NDA) to the EMA.

This is comprehensive and contains all of the study results. On average it takes the EMA 15 months to review an NDA.

If approved, the EMA will give the drug an “On-Label Indication.”

The drug can be marketed for the given indication that is on the label, and if physicians deem it appropriate for other indications they may prescribe it “Off-Label”.

An example of this would be gabapentin, with a brand name of Neurontin. Gabapentin was approved for epilepsy “on-label” but is commonly used “off-label” for pain management in patients with peripheral neuropathy.

Phase four

Once a drug has passed a phase three trial, it is ready to be approved by the EMA, but there is one more stage of testing: phase four.

This is a post-market phase, where the company keeps tabs on possible issues that slipped through the cracks in the previous trials, such as extremely low frequency side effects that only show up when the drug is used by hundreds of thousands of people.

There are two different regulatory approaches and processes leading to drug applications and approvals.

The drug repositioning process is where pharmacy takes drugs that failed clinical programs and make changes in the endpoints of their studies or make changes to the molecule itself in order to get approval.

EMA has approved transdermal drug delivery system only, because of its many significant benefits over traditional drug deliver methods such as:

  1. Convenience of controlling addiction over drugs which may otherwise need frequent dosing
  2. Enhanced bioavailability
  3. More consistent plasma levels
  4. No side-effects because of consistent plasma levels
  5. Convenience of stopping the drug treatment by taking out the patch from the skin
  6. Enhanced patient comfort, as it is painless, simple and non-invasive
  7. Longer period of activeness leading to a reduction in the dosing frequency

EMA must also approve new food additives before they can be used in foods, while products such as X-ray machines and microwaves need to measure up to performance standards.

What EMA essentially does is that it reviews the results of the lab, animal and human clinical testing done by companies to determine if the product they want to put in the market is safe and effective.

Thus it is absolutely necessary for the EMA to test and review products before actually allowing companies to put it out in the market.

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