Difficulties facing PPP active substance renewals

With active substance renewals generally happening every ten years in the EU, the regulatory landscape can shift significantly between renewals or after initial approval. For instance, compounds coming up for renewal under the EU’s AIR-4, AIR-5 or AIR-6 programmes will face increased scrutiny related to their environmental impact.

Demonstrating ongoing safe use of an active substance for the purposes of renewal often requires multiple new studies. This takes time and incurs expense for applicants, as well as generating new data which must be evaluated by the RMS. Setting up a taskforce where multiple entities collaborate over the preparation and submission of a renewal dossier for their common active substance is not mandatory, but it is greatly encouraged. It is also beneficial for the applicants.

When a taskforce submits a single renewal dossier, it cuts the amount of information which would otherwise be supplied. This reduces the likelihood of data discrepancies which have the potential to introduce uncertainty in the evaluation and hinder renewal of approval. It also lessens the burden on the RMS and the whole evaluation system as well as the applicants. However, forming, organising and moderating a taskforce so that it operates effectively can be far from straightforward.

TSG’s Head of Plant Protection, Iain Watt, has experience both as a participant and a technical adviser on taskforces for the renewal of active substances. Here, he addresses some of the questions and difficulties that can arise.

Who should be involved in a taskforce?

Any organisation that wishes to support a given active substance renewal should be allowed to form or join a taskforce with other applicants for that active substance’s renewal of authorisation. A basic taskforce might involve one lead applicant which owns the majority of the data submitted, with additional companies contributing to the preparation and submission costs and thus securing required citation rights. Other scenarios can be more complex, involving various data owners and multiple subcontractors.

It’s often the case that a taskforce forms and begins collaborating within a legal framework agreement at an early stage, with other companies joining at a later date. In this circumstance, a late joiner fee may be applied.

Such eventualities are generally accounted for in a taskforce agreement. To facilitate this, and other aspects of the journey, a taskforce is supported by independent representatives who provide guidance on legal and technical matters.

How do we coordinate new studies?

Active substance renewals require new scientific studies to be generated in relation to data requirements which have evolved over time. This resource-intensive process requires expert input to ensure studies are acceptable and present their findings clearly to facilitate the evaluation.

Engaging an experienced technical consultant is critical to ensure this part of the process runs smoothly. They need enough regulatory and scientific insight to be able to support commissioning the right studies. And they need enough authority to confidently handle any queries or concerns raised by the taskforce members.

Depending on the structure of the taskforce, new studies may be funded (and the resultant data owned) jointly by all members, or by certain members of the group.

What existing data can we use?

Clearly, it’s quicker and more cost-effective to reference existing acceptable studies or use data that’s already held by taskforce members wherever possible. The technical consultant will analyse any available data to ascertain whether it adequately addresses the regulatory requirements.

There are times when one taskforce member can provide a large amount of the required data, reducing or negating the need for further studies. In this situation, the member may be eligible for data compensation from the other taskforce members. On other occasions, the technical adviser may determine that all members bring equally viable data to the table. In this instance, one dataset will be selected, and data compensation may not be required.

Equally, data submitted for earlier authorisations may still be valid. If this is thought to be the case, the technical consultant can prepare a reasoned assessment outlining the rationale for its reuse.

How do we determine the best ‘representative use’?

One potential area of disagreement within a taskforce is the selection of a representative use for the purposes of illustrating safe use. Each member is likely to have its own product uses that it would like to see included. However, the RMS only needs to see evidence of one safe use; adding too many can introduce unnecessary complexity to the evaluation.

On the other hand, evaluations take a long time and new information may come to light while the process is ongoing which can impact the RMS’ conclusions. If only one representative use has been included at the point of dossier submission, and safe use cannot be demonstrated before the evaluation ends, renewal of authorisation will not be granted.

An experienced technical consultant can manage risk through the careful selection of the representative uses for inclusion in the dossier. Ideally, they can involve scenarios which cover both indoor and outdoor applications as well as edible and non-edible crops. The inclusion of a particular use in the active substance dossier, if successful, can make the post-renewal authorisation or reauthorisation of the use easier.

What about our IP and confidential info?

Using a trusted third party to facilitate the taskforce’s work and handle practical aspects of dossier compilation and submission protects joint applicants from possible disclosure of confidential information.

TSG can handle the technical and administrative aspects of dossiers, both for individual and taskforce applications. We’re also proficient in the use of the IUCLID platform which must now be used for the submission and management of active substance dossiers under the EU transparency regulation.

In addition to active substances, we support the renewal of authorisation for plant protection products; this article looks at how to help the process run smoothly.

Contact us at [email protected] to find out how we can aid the planning and preparation of dossiers for plant protection products and their active substances.