Looking at the EU's drug authorization system in the context of the global epidemic

In 2020, the emergence of the new crown pneumonia pandemic has added a haze to this era.
The virus not only tests the public medical systems of various countries, but also challenges the pharmaceutical industry and drug authorization review agencies in various countries
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1.
The EU's three types of advance review drug procedures

The EU does not have a separate emergency use authorization system.
It is based on the review process of general drug authorization (see Figure 1-1).
The European Council (EC) and the European Medicines Agency (EMA) "2004" [Regulation (EC) No726 /2004] established three review procedures: accelerated review, conditional marketing authorization and special review (see Figure 1-2)
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1.
1 Accelerated review

Reg.
726/2004/EC Article 14 (9) Accelerated Assessment (Acceleratedassessment) stipulates that from the perspective of public health, especially from the perspective of therapeutic innovation, applicants can apply for accelerated assessment, and the review time limit will be reduced from a minimum of 210 days to a minimum of 150 Days
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Among them, drugs of major public health interest refer to whether the drug has major public health benefits certified by the applicant and evaluated by the European Commission for Medicines for Human Use (CHMP) according to the specific circumstances.
The evaluation criteria include: (1) There are unmet medical needs and availability Methods of prevention, diagnosis or treatment
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1.
2 Conditional marketing authorization and its emergency vaccine authorization procedures

Attached marketing authorisation (Conditional marketing authorisation, CMA) according to Reg.
726/2004/EC regulations, after consultation with the applicant, certain specific obligations can be attached to approve the marketing authorisation
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The accessory marketing authorization procedure also includes the emergency authorization procedure for vaccines
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1.
3 Simulated vaccine procedure under special review (accelerated review procedure for virus strain changes)

Exceptional circumstances are a review process for specific types of drugs.
These drugs are usually unable to provide the efficacy or safety under normal conditions of use due to the rarity of the treatment conditions, the incomplete collection of information, or the non-compliance with ethical requirements Sexual data
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The simulated vaccine is based on disaster preparedness purposes and is a vaccine produced against influenza viruses that have not yet been pandemic, but its composition and safety for human use are consistent with the final clinical vaccine, except that the influenza virus strains are different
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Figure 1-1 EMA drug review process

Figure 1-2 EU emergency authorization procedure

Figure 1-3 General review process and rolling review process

2.
EU drug review case

2.
1 The new crown vaccine applies for marketing through the vaccine emergency authorization procedure

During the 2020 COVID-19 global pandemic, Pfizer/BioNTech’s BNT-162b2 vaccine (Comirnaty vaccine) submitted emergency use authorization applications to the United Kingdom and the European Union, respectively
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The British Medicines and Healthcare Products Regulatory Agency (MHRA) (which is one of the main components of the EMA before Brexit, and the review process is the same after becoming an independent review agency) and the EMA will conduct a rolling review of vaccine data from October 6
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On December 2, the United Kingdom temporarily approved the use of Pfizer/BioNTech's BNT-162b2 vaccine in accordance with Article 174 of the 2012 Human Medicine Regulations in the United Kingdom, becoming the first Western country to approve the use of the new crown vaccine
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EU spokespersons criticized the UK's measures as "hasty and hasty".
They chose a more conservative review schedule and completed the emergency authorization vaccine procedure for the vaccine on December 21 to approve the market
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※Note: Article 174 of the 2012 Human Medicine Regulations of the United Kingdom stipulates that government authorities can temporarily approve the sale or supply of special medicines under four types of circumstances
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Including pathogens, toxins, chemicals, and nuclear radiation, four types of suspected or confirmed spread of health hazards to humans
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2.
2 Zabdeno and Mvabea-a group of Ebola vaccines authorized through special review

Zabdeno and Mvabea are a group of vaccines that mainly target Ebola virus and are injected in two doses
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The production background of these two types of vaccines is the Ebola hemorrhagic fever outbreak that broke out in Africa in June 2020.
The European Union provides medical assistance to African countries
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Zabdeno and Mvabea are two vaccines containing Ebola virus protein modified from adenovirus and modified Ankara pox vaccine virus, respectively, and are reviewed through the simulation vaccine program
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Although the level and duration of protection against the virus have not yet been determined, the European Medicines Agency believes that the benefits of vaccines may be very important to help control the epidemic and prevent deaths, and in terms of safety, most of its side effects are mild in severity To moderate, short duration
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Therefore, EMA believes that the benefits of Zabdeno and Mvabea vaccines outweigh their risks, so it authorized their use in the EU on July 1 of that year
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2.
3 Onpattro-Orphan Drug Passed Accelerated Review

Onpattro is the first siRNA drug approved by the US FDA and the European Union for the treatment of nerve damage caused by hereditary transthyretin (hATTR) amyloidosis
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It was designated as an orphan drug on April 15, 2011 .
EMA believes that it meets the conditions for the accelerated review (that is, the major public health interests mentioned above).
After the accelerated review of Onpattro was carried out for 150 days, it was granted a marketing license in the European Union on August 27, 2018
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In addition to Onpattro, many orphan drugs have also been authorized through accelerated review; however, there are also orphan drugs that have been authorized through a special review path due to insufficient information in the clinical trial process, such as Vyndaqel, a treatment for familial amyloid.
Drugs for polyneuropathy
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2.
4 The current EMA's approval of new coronary pneumonia-related drugs

EMA has adopted special measures with high transparency for the drug review process related to the new coronary pneumonia, and frequently publishes review information and data for the new drug review process, but does not shorten the overall review time
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In mid-2020, EMA approved 97 drug marketing licenses, including 6 accelerated review, 13 conditional listing, and 5 special review.
Only the previously mentioned Comirnaty vaccine and one therapeutic drug are related to new coronary pneumonia.
Veklury
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Up to now, there are 4 kinds of new coronavirus vaccines authorized in the EU (the vaccines launched by Pfizer, AstraZeneca, Modena and Johnson & Johnson respectively); in the EU this year, there are only 2 new drugs for new crown pneumonia that have received marketing authorization (Regkirona With Ronapreve), 1 drug is under rolling review (Evusheld), and 5 drugs have been applied for review that has not yet started
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3.
Summary

EMA has diverted the urgency of drug review by setting up multiple review procedures
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Orphan drugs, innovative drugs, and other drugs for various intractable diseases, such as AIDS, malignant tumors and other difficult problems in modern medicine, are often allowed to obtain authorization in advance through the path of accelerated review or even special review, and enter the medical treatment as soon as possible.
The market allows patients to benefit from new drugs as soon as possible; and when faced with various public health events, EMA can authorize targeted vaccines through simulated vaccine procedures and emergency vaccine procedures to face the epidemic as soon as possible
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These types of processes that can speed up the review process are not only the EU's incentive measures for all kinds of innovative drugs and orphan drugs, but also ensure that the EU's review system has a certain emergency response capability in the face of major public health incidents, and guarantees medicines.
The safety and effectiveness
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This has certain reference value for the further improvement of China's drug management system
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However, as a transnational regional organization, the EU has a rigid implementation process for this set of review procedures.
It cannot pass legislative tough methods like the former EU member state, or the U.
S.
FDA uses a mature set of emergency procedures.
Use the authorization process to speed up the emergency review method to promote the vaccine as soon as possible in response to the crisis
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The European Union’s drug emergency authorization process is relatively conservative in the context of the global epidemic.
For the COVID-19-related drug review process, EMA chose to adopt more transparent and frequent information disclosure rather than adopting a compressed time method
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