The EMA reviews 1,800 generic medicines for “deficiencies in the validity and reliability” of clinical trial data

Blisters of different medications.Yves Herman (Reuters)

Since last July, the European Medicines Agency (EMA) has been reviewing a total of 1,800 medicines marketed in the European Union – almost a hundred of them in Spain – for “deficiencies related to the validity and reliability of the data obtained in the trials.” “clinical”, as revealed this Monday in a statement by the Spanish Agency for Medicines and Health Products (AEMPS), dependent on the Ministry of Health.

The investigation, the EMA explains in a letter published on its website, began at the request of the AEMPS after “an inspection of good clinical practices that raised serious doubts” about the results of the bioequivalence studies presented by around thirty from pharmaceutical companies. In all cases, the drugs under review had been “authorized (by the EMA and the countries’ agencies) on the basis of studies carried out at the facilities of Synapse Labs,” a company based in Kharadi (India).

A spokesperson for the AEMPS states that, for now, it has not been necessary to order the withdrawal of any drug due to findings related to the EMA review. “These are medications that have been on the market for quite some time without the surveillance systems having detected safety problems so far. The data under review are those referring to bioequivalence, which seek to demonstrate that a generic medication is interchangeable with the original,” explains this spokesperson.

The EMA, for its part, maintains that “it will review the available data to determine whether any action is necessary to protect public health.”

Ángel Luis Rodríguez de la Cuerda, general secretary of the Spanish Association of Generic Medicines (Aeseg), explains that “bioequivalence studies are those that are carried out before a generic medicine is put on the market with the aim of demonstrating that “They have the same effectiveness, safety and quality as the branded originals.”

These works are carried out when the patent of the brand-name drug has already expired (or is about to do so) and the objective is the entry into the market of cheaper competitors that meet the same quality and safety requirements. These types of trials last much less time—a few months versus several years—and require a smaller number of patients than those carried out when a new active ingredient hits the market.

According to Rodríguez de la Cuerda, “the action of the AEMPS and the EMA is important because it guarantees patient safety and is a good example that illustrates the strict quality levels to which the entire pharmaceutical sector and, especially, the of generics.”

Synapse Labs is one of the large global companies that carry out studies like those now investigated. Referred to in the sector as contract research organizations (CROs), “these companies can carry out part or all of the clinical trials and are contracted by pharmaceutical companies or any other entity that promotes research” explains Enrique Castellón, former undersecretary of the Ministry of Health and advisor to the venture capital fund Cross Road Biotech.

The objective of using a CRO for pharmaceutical companies is to gain management agility and save costs. “It has been a widespread practice for decades and is subject to strict regulation. CROs must be accredited in each country and their activity, even if it is carried out in third countries, is subject to the controls established by European regulations,” adds Castellón. It was precisely in one of these controls, the inspection of good practices of the AEMPS, when the investigated deficiencies were detected.

Among the companies included in the list of drugs under review are several of the largest pharmaceutical manufacturers of generics: Sandoz, Stada, Cinfa, Mylan… A spokesperson for the former explains that the company is waiting for the next steps to be taken. to give the EMA. “This is a global issue that affects more companies and countries, so our position focuses on working in coordination with Medicines for Europe (the European association of generic manufacturers) and the rest of the institutions involved. Internally, we are also coordinated between the different Sandoz departments to address the needs that arise while waiting for the EMA evaluation,” adds this representative.

Mar Fábregas, general director of Stada Spain (and also president of Aeseg) claims to be “attentive to the results of the review undertaken by the EMA, as well as any other specifications of the regulatory bodies”, without for now declaring that she has adopted no special measures. In any case, the company reiterates its “commitment to the maximum guarantees of drug safety.”

In its statement published this Monday, the AEMPS orders all pharmaceutical companies that have used the services of Synapse Labs to review whether the medicines authorized with their studies are already included in the list of 1,800 drugs published by the EMA. Otherwise, they must notify the agency within seven calendar days so that the data from their studies can also be reviewed.

The investigation by the European agency, carried out by its Committee for Medicinal Products for Human Use (CHMP), is carried out in compliance with article 31 of Directive 2001/83/EC, which establishes a “community code on medicinal products”, according to the EU regulations. This type of process is activated “when the interest of the Union is at stake in relation to issues related to the quality, safety or effectiveness of a medicinal product or a class of medicinal products”, concludes the EMA information.

The process initiated may continue for several months and will conclude with an opinion from the Committee which will subsequently serve as the basis for the final decision to be adopted by the European Commission.

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