The maximum timeframe for the evaluation
of an MAA by the CHMP under the centralized procedure is 210 days after receipt of a valid application. This period will be suspended
until such time as the supplementary information requested by the CHMP, has been provided by the applicant. Likewise, this time-limit
will be suspended for the time allowed for the applicant to prepare oral or written explanations. When an application is submitted
for a marketing authorization in respect of a drug which is of major interest from the point of view of public health and in particular
from the viewpoint of therapeutic innovation, the applicant may request an accelerated assessment procedure. If the CHMP accepts
such request, the time-limit of 210 days will be reduced to 150 days but it is possible that the CHMP can revert to the standard
time-limit for the centralized procedure if it considers that it is no longer appropriate to conduct an accelerated assessment.
If the CHMP concludes that the quality,
safety and efficacy of the product are sufficiently proven, it adopts a positive opinion. This is sent to the European Commission
which drafts a decision. After consulting with the Member States, the European Commission adopts a decision and grants a marketing
authorization, which is valid for the whole of the European Economic Area, or EEA. The marketing authorization may be subject to
certain conditions, which may include, without limitation, the performance of post-authorization safety and/or efficacy studies.
The EMA has various programs, including
accelerated assessment, conditional approval, and PRIME, which are intended to increase agency interactions, expedite or facilitate
the process for reviewing drug candidates, and/or provide for initial approval on the basis of surrogate endpoints. One or more
of our product candidates may qualify for some of these expedited development and review programs. Even if a drug candidate qualifies
for one or more of these programs, the EMA may later decide that the drug candidate no longer meets the conditions for qualification.
Eligibility to the PRIME scheme is limited to products considered to offer a major therapeutic advantage in high unmet need populations.
PRIME is a voluntary scheme aimed at enhancing interaction and early dialogue with developers of promising medicines through the
early appointment of the product Rapporteur, optimizing development plans and speeding up evaluation so these medicines can reach
patients earlier. Products benefiting from PRIME can expect to be eligible for accelerated assessment at the time of application
for an MAA.
European Union legislation also provides
for a system of regulatory data and market exclusivity. According to Article 14(11) of Regulation (EC) No. 726/2004, as amended,
and Article 10(1) of Directive 2001/83/EC, as amended, upon receiving marketing authorization, new chemical entities approved on
the basis of a complete independent data package benefit from eight years of data exclusivity and an additional two years of market
exclusivity. Data exclusivity prevents regulatory authorities in the European Union from referencing the innovator’s data
to assess a generic (abbreviated) application. During the additional two-year period of market exclusivity, a generic marketing
authorization can be submitted, and the innovator’s data may be referenced, but no generic medicinal product can be marketed
until the expiration of the market exclusivity. The overall ten-year period will be extended to a maximum of eleven years if, during
the first eight years of those ten years, the marketing authorization holder, or MAH, obtains an authorization for one or more
new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant
clinical benefit in comparison with existing therapies. Even if a compound is considered to be a new chemical entity and the innovator
is able to gain the period of data exclusivity, another company nevertheless could also market another version of the drug if such
company obtained marketing authorization based on an MAA with a complete independent data package of pharmaceutical test, pre-clinical
tests and clinical studies. However, products designated as orphan medicinal products enjoy, upon receiving marketing authorization,
a period of 10 years of orphan market exclusivity. See also “—Orphan Drug Regulation” below. Depending upon the
timing and duration of the EU marketing authorization process, products may be eligible for up to five years’ supplementary
protection certification, or SPC, pursuant to Regulation (EC) No. 469/2009. Such SPCs extend the rights under the basic patent
for the drug.
In the EU, the pediatric regulation (Regulation
(EC) No 1901/2006 as amended) requires sponsors to submit a pediatric investigation plan at the end of Phase 1. This plan will
provide the details of the quality, non-clinical and clinical studies required to support the authorization of a pediatric indication.
Additional rules apply to medicinal products for pediatric use under Regulation (EC) No. 1901/2006. Potential incentives include
a six-month extension of any supplementary protection certificate granted pursuant to Regulation (EC) No. 469/2009, but not
in cases in which the relevant product is designated as orphan medicinal products pursuant to Regulation (EC) No. 141/2000,
as amended. Instead, medicinal products designated as orphan medicinal product may enjoy an extension of the ten-year market exclusivity
period granted under Regulation (EC) No. 141/2000 to twelve years subject to the conditions applicable to orphan drugs.