Österreichische agentur für gesundheit und ernährungssicherheit gmbh lessons learned and...
TRANSCRIPT
Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbHwww.ages.at
Lessons learned and improvement of the zonal system
Christian ProhaskaAustrian Agency for Health and Food Safety (AGES)ECPA/ECCA Conference 2015, Brussels
www.ages.at 2
Expectations
- One MS´s assessment on behalf of other MS
- Speeding up of authorisations
- Increase the level of harmonisation between MS
- Keeping the timelines
www.ages.at 3
The zonal system? – Worth thinking about!
www.ages.at 4
Create an update of 1107/2009 would be an option
How long would that take?
Danger of making things worse than they are
Focus on the existing system only…
www.ages.at 5
Complaints? Expectations?
Timelines/capacities
Harmonisation (procedural and technical)
Article 40 (mutual recognition)
Article 43 (renewal of the products)
Article 51 (minor uses)
And many much more…
www.ages.at 6
Capacities/timelines
Submitted and intended applications for new products (2012 – 2014)
Date: December 2014
To be considered: different structures of the authorities, number of experts, history, agriculture….
www.ages.at 7
Capacities/timelines
Keeping timelines (new applications according to 1107/2009 considered only) – e.g. AT as zRMS
* 5 days – 3 months** 25 days – 2 months
Time Total number of authorizations (AT acting as zRMS)
On time Delay
July 2011 – July 2012 17 3 14*July 2012 – July 2013 11 5 6**
www.ages.at 8
Capacities/timelines
It becomes more and more obvious, that every MS failed/will fail to keep the timelines
Additional workload to be considered
- Comparative assessment
- Article 43 applications
www.ages.at 9
Capacities/timelines
Why is everybody complaining about capacities? - We are in the same situation as under Directive 91/414/EEC (number of applications, work load….)
- Hypothesis: For the new system, every MS tries/tried to keep the timelines, but….
www.ages.at 10
Capacities/timelines – solutions?- Increase the number of experts (will not solve the problem)?
- Reflect on the organisation in each MS (one body instead of several numbers of bodies) – political issue in MS!
- Process improvement (authorities; procedural and assessment)
- Increase work-sharing within the zone and between zones (without complicating the system, like e.g. additional commenting phase)?
- Zonal secretariat? Will not solve the issues with technical assessments!
- Harmonisation!
www.ages.at 11
Harmonisation - Aim
Increase the level of knowledge of experts (because of increase of scientific exchange)
Increase the level of trust between MS (in order to simply rely on the zRMS´s assessment)
Preconditions: Follow the agreed guidance (even if not
in favour)!
Harmonisation means the will for compromise!
www.ages.at 12
Harmonisation – procedure/examples
Substance data – when to be used (product assessment)?
- Use of new substance data only if needed in order to show a safe use and/or flagged by the applicant as “adverse data” -> otherwise, use existing LoEPs only!
- Data gaps identified in EFSA conclusion
If data gaps substantial -> no approval of the active or confirmatory information (to be dealt with at EU-level!)
If not that substantial – to be assessed for renewal of the active
www.ages.at 13
Harmonisation – procedure/examples
Guidance on Article 34
- Composition of the PPP is comparable to the reference product (in the sense of GD on significant and non-significant change) and data are out of protection
- No new studies needed – no new assessment (part A and C only!)
- To be further elaborated if products are not comparable in the sense of the GD on significant and non-significant change
www.ages.at 14
Harmonisation – procedure/examples
Label extensions (Article 33 applications)
- If new use fall within the risk envelope approach for existing uses (even 91/414 registrations are concerned)
Need to assess new studies only (e.g. residues, efficacy)
No need to re-assess the existing uses and/or the existing risk assessment
Every MS to follow the approach?
www.ages.at 15
Harmonisation – technical issues
Harmonisation Workshops
- Toxicology (Berlin, June 2014; follow up in Vienna, June 2015) – interzonal
- Ecotoxicology (Wageningen, June 2014; follow up in Vienna, April 2015) – central zone only
- Fate and behaviour (Vienna, November 2014) – central zone only
- Risk harmonisation under BTSF? COM to consider!
www.ages.at 16
Harmonisation – technical issues
Harmonisation Workshops – critical remark
- Accumulation of worst case assumptions? - Will/possibility for harmonisation?
Supervising body needed:
“Director´s meeting” at zonal level (established for the central zone):
- Safeguard for the harmonised issues to be followed by MS- If no decision at experts level, the directors will decide
www.ages.at 17
Harmonisation – technical issues
National addendum vs core assessment
Do not use national specifics in thecore dRR
Use EU-agreed methodology in the coredRR, e.g. Focus model for fateassessment!
Harmonisation workshops needed in order to reduce und understandthe national specifics
www.ages.at 18
Harmonisation – technical issues
Technical GD (EFSA Guidance)
Development of GD:
- All stakeholders to be taken on board (industry)- Transitional measures/periods to be considered- Feasibility/practicability of the GD for regulatory purposes to be considered
Examples:Operator exposure GD??Guidance on dermal absorption
Note: It is still a MS/zonal issue, when to use what for product evaluation
www.ages.at 19
Article 40 – Mutual recognition- Accelerated procedure (120 days for “real” 1107/2009
registrations)- Precondition: same uses and same GAPs as the reference MS- Registration not to be refused because on efficacy grounds only
- Do really all MS follow? - Some MS refuse application if efficacy not assessed in the corresponding EPPO zone
Recommendation:Not to include MS in Article 33 application (cMS) – rather go for Article 40 – at least for MS who follow the rules
www.ages.at 20
Article 43 – Renewal of the products
• Preconditions for application according to Article 43:
- GAPs remain unchanged (what if the GAP has to be changed because of new end-points?)- No new uses!- No new cMS (for which the product is new)!- No formulation change! (except: non-significant change according to GD SANCO/12638/2011)
If preconditions are not fulfilled -> Article 33 application
www.ages.at 21
Article 43 – Renewal of the products
MS may grant extension of the concerned authorisation until studies are made available [valid for cat 4 studies only]
Cat. 4 studies are:
- Studies in order to comply with new end points and time is too short to produce the studies required (e.g. mesocosm studies, residue trials; efficacy trials if necessary because of changed end points -> lowering of amount active/ha)
www.ages.at 22
Article 43 – Renewal of the products
• For the time being: Interpretation of Article 43(6): “reasons beyond the control of the authorisation holder”
To be considered in the Guidance Document “Renewal, Withdrawal and Amendment of Authoristaion” (“sake of harmonisation”!)
• For the “near” future: Change of the wording of Article 43.2 and/or Article 43.6?
www.ages.at 23
Article 43 – Renewal of the products
Mixed products (containing > 1 active) Consequently, for the individual sections only product data to be considered:
- section physchem properties (Storage stability only)- section analytical methods (no need to be looked at)- section toxicology (toxicity data of the product including dermal
adsorption)- section residues (no need to be looked at)- section fate (no need to be looked at)- section ecotox (e.g. bees, arthropods, earthworms, plants, aquatic organisms) - part C (composition of the product only)
Once the 2nd substance is renewed, there is no need to look at the 1st substance again
www.ages.at 24
Article 51 – Minor uses
• Zonal system applies as well• Accelerated procedure possible
(no efficacy, residue trials only*))• Grower´s associations may/should
look for cooperation across the border- Identification of common minor uses in different MS- Joint generation of residue data needed
• Implication of comparative assessment:Candidate products with minor uses – not to perform a comparative assessment at all - Increased motivation for application holders to increase the level of investment for minor uses-----------------------------*) If new use is within the risk envelope
www.ages.at 25
The house is damaged, but still possible to make it worth living in!
Source: Steffi A.