Concertation Procedure Research Articles

What Can be Learned from Experience Gained using the Old European Concertation Procedure?

The feasibility of collecting detailed information on the marketing authorization of new medicines in the European Union was investigated by conducting a study to obtain data on the use of the concertation procedure. Ten pharmaceutical companies provided information on 13 biotechnology or high technology products going through the procedure between 1988 and 1993. The main reason for choosing the rapporteur state was for its experience. Discussions with the rapporteur were considered useful, particularly for guidance, facilitating timely responses to questions and forestalling divergence of opinion. The total length of time of the procedure ranged from 272-882 days. The length of time to national marketing authorization following a favorable Committee for Proprietary Medicinal Products (CPMP) opinion ranged from 5-1,374 days. The rapporteur authority tended overall to be the quickest, and conversely, authorities dissenting in the original CPMP opinion were among the slowest to grant national authorization....

Experience with the Concertation Procedure: Bridge to the Centralized Procedure

The concertation procedure has been a success in many respects, and will serve as a bridge to the future centralized procedure in the EC. Since the procedure's implementation, the distribution of rapporteurs has become evenly spread among Member States. Approval rates for products using this system have been quite high. One major success of the concertation procedure is that it has brought Member States closer together. It will also ease the transition to a centralized procedure.

BGA Experience with the Concertation Procedure

Germany's experience with the concertation procedure has been fairly successful. This paper compares the time frame for approval of applications through the concertation procedure to multi-state procedures and national procedures. Although Germany takes longer than some Member States, it is not nearly as bad as others. The BGA is working hard to decrease approval times.

Experience of the Netherlands Regulatory Agency with EC Concertation Procedures

The experience of the Dutch Medicines Evaluation Board as rapporteur in the concertation procedure has been a successful learning experience. We begin with informative discussions with the applicant in the presubmission phase, emphasizing close contact between the company and the authority experts. After the dossier is sent and objections come in from the Member States, we prepare a clear, consolidated list of objections. When the applicant replies, we make an assessment report on that reply. In most cases, agreement is reached on one single summary of product characteristics, and harmonization is achieved.

Registering A List B New Chemical Entity via the Concertation Procedure: A Case History

Marion Merrell Dow's (MMD) one experience with the concertation procedure was for a product that did not automatically qualify for the concertation procedure, that is, it is not a List A product but a new chemical entity which met one of the List B criteria. The following aspects are covered: a brief background on the product; why this route was chosen and what was involved in obtaining the List B status; the timetable of events; some of the general issues that arose during the procedure; and finally, some rather limited conclusions from this one experience.

EC Registration of Genotropin® (Recombinant Human Growth Hormone) via the Concertation Procedure

By the time the concertation procedure became operable in July 1987, Genotropin® was already involved in registration procedures in most EC countries. However, Kabi Pharmacia was able to use the concertation procedure for variations of Genotropin®, with Denmark as rapporteur. Our experience highlights the importance of the rapporteur. Our rapporteur, together with the Member State authorities and the CPMP, worked hard to meet the deadlines. However, national approval times after the. CPMP opinion need to be improved.

Concertation Procedure for Variations of Biotech Products

For many years, there were no clear guidelines for registering variations—new indications, new dosage regimens, new strengths, or new pharmaceutical formulations—for biotech products. In 1989, F. Hoffmann-LaRoche had a product—Roferon-A—which was approved for different indications in different Member States. In order to work toward harmonization as well as approval for new indications, we began to piece together information from BIRA, BGA, MCA, and CPMP. In April 1990, we began the concertation procedure for one variation (a new indication) of Roferon-A; since then we have successfully completed others, both new indications as well as harmonizations. By 1993, we hope to have a harmonized summary of product characteristics.

EC Registration of Proleukin® (Recombinant Interleukin) via the Concertation Procedure

In April 1988, EuroCetus* submitted a marketing authorization application for Proleukin® to the CPMP using Italy as rapporteur. Thirteen months later, we received a positive opinion. Although the results of the concertation procedure were favorable, we did encounter some practical problems along the way. The views presented here are those of the author, not necessarily the company.

Drug Safety in the European Community

By 1992 the European Community's pharmaceutical legislation will cover all industrially produced medicines, including vaccines, blood products and radiopharmaceuticals. The quality, safety and efficacy requirements have been harmonised, as have certain aspects of procedures for marketing authorisation or for manufacture. The complete texts of the 'Rules Governing Medicinal Products in the European Community' were published recently. Pharmaceutical companies have 2 types of European Community registration procedures available, which are intended to facilitate the adoption of a common position by the member states. The experience gained with the procedures of the Committee for Proprietary Medicinal Products (CPMP) has highlighted opportunities for closer cooperation, either before national decisions (concertation procedure) or after such decisions (multi-state procedure). The installation, in 1993, of a single European market without borders implies that medicinal products should be able to circulate throughout the European Community with the same conditions attached to their marketing. Monitoring the adverse effects of medicinal products (pharmacovigilance) is also a major issue. The existing arrangements for exchanging postmarketing information will be reinforced, in future, by strengthening the legal provisions already in force.

EEC policy for regulation of biotechnology products

AbstractThe most important regulative EEC decisions concerning biotechnology products are the creation of the ‘concertation procedure’ for EEC‐wide registration (Council Directive 87/22/EEC), and the authorization of the CPMP to adapt test requirements according to technical progress (Council Directive 87/19/EEC).Test requirements (Notes to Applicants) on pharmaceutical quality (MAB's, rDNA‐derived products‐cell substrates in preparation) and on preclinical safety testing have been published.The pre‐clinical notes to applicants seek to overcome the current case‐by‐case procedure, which is unsatisfactory both for industry and regulatory authorities, by structuring the heterogeneous variety of products into product related test schemes, thus giving better orientation for applicants for marketing authorizations.There is a horizontal structure (4 product groups: hormones, cytokines, regulatory peptides/blood products, MAB/immunizing agents) and a vertical structure (depending on the biochemical deviation from the naturally occurring product). Allocation of a given product horizontally will determine the strategy, and vertically the depth of testing. Additional remarks concerning methods allow for deviations from test schemes developed for chemical products, in relation to species‐restricted lack of response and immunotolerance. The concept of deriving test schemes from product characteristics has proved successful, but is subject to further improvement (e.g. including as additional structuring elements the generic familiarity, and use‐related criteria spanning from substitution to pharmacodynamic effectuation with supraphysiological dose regimes), and making better use of the present knowledge of sera, vaccines and other biologicals (and their regulation), thus facilitating easier planning and performance of relevant pre‐clinical safety testing.