Perspectives from a new Mem ber State Accession preparation I - - PowerPoint PPT Presentation

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Perspectives from a new Mem ber State Accession preparation I - - PowerPoint PPT Presentation

Jun 17, 2023 199 likes •579 views

Perspectives from a new Mem ber State Accession preparation I Reinforcing patient safety in Europe Romaldas Maciulaitis and Gintautas Barcys State Medicines Control Agency Topics Phasing-in Lithuanian national competent authority (SMCA)

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Perspectives from a new Mem ber State Accession preparation I Reinforcing patient safety in Europe

Romaldas Maciulaitis and Gintautas Barcys State Medicines Control Agency

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 2

Topics

  • Phasing-in Lithuanian national competent

authority (SMCA) to EU network

  • Main safety activities
  • Lessons learned
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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 3

Lithuanian NCA: Sm all Agency in a Sm all Country

Population (in millions): ~ 3.0 (in 2011) from ~ 3.7 in 1990) Experts’ monthly salaries (netto) ~ $1000 (in 2010) from ~ $100 (in 1995)

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 4

Populations and em ployees per Agencies

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 5

State Medicines Control Agency ( SMCA) and regulatory fram ew ork

Medicines ( including inspections)

Food supplem ents Medical devices Veterinary

SMCA Accreditation Agency Veterinary Agency Ministry of Health Lithuanian Governm ent

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 6

SMCA

~ 1 0 0 internal em ployees ~ 1 3 0 before crisis + 8 external contractors + 2 external experts

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 7

Challenges during “Phasing-in” and im plem enting ACQUI S ( 1 / 2 )

  • Continuously changing ACQUIS

– (2 Pharma laws → 1 Consolidated law + Orders)

  • Challenges with SOPs, deadlines, communication

with applicants

=> Do not intent to be ideal everywhere from the very beginning => Do not just simply copy CRP practices for NRP purposes

  • Too limited number of priorities from the

activities expected by upper government bodies

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 8

Challenges during “Phasing-in” and im plem enting ACQUI S ( 2 / 2 )

  • Too long time for MA procedures and sometimes

just minimal quality in performances

  • Too big turnover of experts makes additional

burdens to keep constant national competence

  • Need for competence development for active

participation in EU regulatory framework

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 9

I m pact on national authorizations

  • Conversion of numbers of herbal and “medical

purpose” products based on revised benefit/ risk assessments

  • Not-upgraded dossiers

=> Do not mix regulatory pharma science with economic politics => Do not assume that applicants always know what they are doing => Learn how to translate scientific judgment into legal language

  • Authorization of “ex-concertation” type of

products

  • Availability problems, including limited

consistency in supplies to pharmacies

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 10

After 5 years w e finally confirm ed a status of food supplem ent for popular MP

Validolis – ne vaistas, o m aisto papildas

2009-07-21 Valstybinė visuomenės sveikatos priežiūros tarnyba prie Sveikatos apsaugos ministerijos (VVSPT) informuoja, kad nuo š. m. liepos 1 dienos validoliu prekiaujama kaip maisto papildu. VVSPT atkreipia dėmesį į tai, kad maisto papildas yra ne vaistas, o maisto produktas, neturintis gydomojo poveikio ir nevartotinas jokioms ligoms gydyti. Lietuvoje validolis nebepriskiriamas vaistams nuo 2003 m. Valstybinė vaistų kontrolės tarnyba atsisakė jį registruoti kaip vaistą, nes nėra įrodyta, kad jis padėtų sergant kokia nors liga. 2004-aisiais validolis buvo įtrauktas į medicininės paskirties produktų sąrašą, kuris š. m. liepos 1 dieną panaikintas. Ilgą laiką validolis vartotas esant širdies veiklos sutrikimams.

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 11

I ron products Food supplem ent Medicinal product

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 12

I m pact on National MA procedures

Dramatically changed profile

  • f procedures:
  • decrease in NRPs
  • constant increase in

MRP/ DCP

  • introduction of CRPs

Evolution of Marketing Autorisations in Lithuania (including all strengths and forms)

1000 2000 3000 4000 5000 6000 2004 2010 Post Accession MRP/DCP Post Accession NRP Pre Accession NRP

2 0 0 4 -0 4 -3 0 2 0 1 0 -1 1 -0 1 4 7 9 3

4 6 0 1

2 0 1 7 1 4 4 2 4 4 0

Evolution of MA in Lithuania ( including all strengths and form s) NRP NRP MRP DCP

New NRP

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 13

Tendencies in procedures

Medicinal products in national registry Proportions 2007 2008 2009 2010 2007 2008 2009 2010

TOTAL NRP NRP

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 14

Tendencies in procedures

Authorisations Renewals

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 15

As a consequence, medicines availability is not always sufficient: the absence of essential ones, such as:

  • Anticoagulants – heparinum
  • Hormones – hydrocortisonum
  • Antibiotics – izoniazidum, amphotericinum, tazocinum
  • Cardiovasculars – nitroglycerinum, clonidinum, labetololum,

prazosinum, norepinephrinum, digoxinum inj., verapamilum inj.

  • Immunosuppressants: tacrolimus (all formulations), MMF i/v,

ciclosporinum i/v

  • Other – 40% glucosum, calcium i/v, and various antidotes

Availability problem s used to be observed

  • nce upon a tim e….
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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 16

Different additional measures have to be introduced to overcome the shortages putting with an additional burden to all stakeholders:

– Patient named supply chains – Special hospital supply arrangements – Prioritizations in MA procedures, including the for variations Em ployed solutions to availability problem s in Lithuania

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 17

Topics

  • Phasing-in Lithuanian national competent

authority (SMCA) to EU network

  • Main safety activities

– Safe, or not safe: that is a very relative question… like beauty…

  • Lessons learned
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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 18

Main regulatory activities for safety

  • Pre-m arketing safety evaluations
  • NRP
  • MRP/ DCP
  • CRP
  • Pre-m arketing clinical trials
  • Post-m arketing safety evaluations
  • ADR reporting and proceedings
  • PSUR, including EU W orksharing
  • PhW system s
  • DHCP, “Dear Patient” letters, teaching m aterials
  • Post-m arketing safety trials
  • Quality inspections in pharm acies
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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 19

ADR reporting

Serious Total

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 20

Applications for Clinical trials

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 21

Reports about quality defects ( in 2 0 1 0 ) n= 6 4

Labeling 24 (38%) Quality defects 22 (34%) Productions in pharmacy 9 (14%)

Reports from manufacturers 9 (14%) SMCA laboratory reports 55 (86%)

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 22

Quality inspections and defects

Medicines Extemporal production Pure/Water for injection Active substances n n n n Labeling n Non-compliant

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 23

Topics

  • Phasing-in Lithuanian national competent

authority (SMCA) to EU network

  • Main safety activities
  • Lessons learned
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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 24

Lessons learned: 1 0 “DOs”

(1)Strategic positioning of NCA in Big EU

=> Do not limit NCA to national competences only

(2) Follow examples of those NCAs that do control flow of their budgets (3) Invest into key national scientific competences (4) Make use of administrative support available from EU, including IT developments ( 5 ) Utilize w orksharing opportunities of EU regulatory fram ew ork

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 25

Mano galva, nuolatinė nepriklausomos Lietuvos vyriausybių ir VVKT administravimo kaita neleido suformuoti ilgalaikės strategijos ekspertų kompetencijos ir motyvacijos atžvilgiu

.. Firstly, negotiate the strategic balance betw een national and EU priorities

1 9 9 0 1 2 0 1 0 2 0 0 0 3 2 6 5 4 7 8 1 0 9 1 1 1 2 1 3 1 4 1 5 2 0 0 4

EU 2 ( + 2 )

Appointm ents

  • f HoA

Governem tns ( stabilisation in EU)

4 ( + 1 )

= > Do not experim ent in key areas

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 26 7,1 7,3 9,1 10,2 7,8 5,9 2 4 6 8 10 12 2005 2006 2007 2008 2009 2010

Metai

Suma, mln. Lt

Budgetary Conditions of the Agency

Years Total Budget (in Mln Litas; 1 Euro = 3.45 Lt)

↑80% of incomes are from MA

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 27

.. E.g., by avoiding unnecessary w ork

.. Breakthrough im plem enting fast-track procedures

= > Do not spend too m uch effort on not essential activities

Type II variations

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 28

~ 30 %

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 29

Lessons learned: 1 0 “DOs”

(6) Start contributing to EU network asap (7) Employ regional initiatives (multilingual packages, GMP inspections) (8) Initiate pro-active agreements with other stakeholders, including the applicants

=> e.g., do not employ WEU to replace generic application or MRP/DCP => e.g., consolidate non-essential SmPC changes during renewal

(9) Select 4 – 5 persons for key areas and motivate them to do long-term commitments

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 30

30

Total num ber of m em bers and alternates Note: CHMP, BW P, BPW P, EW P, GTW P, QW P, PEG, PgW P, PhVG, SW P, SAW P, VW P, BMW P, CPW P

Count of m em bers and alternates in the CHMP and W Ps

45 37 34 34 29 23 18 18 18 18 15 14 14 14 14 12 11 11 10 10 10 10 10 9 9 7 4 5 10 15 20 25 30 35 40 45 50 DE UK BE NL FR IT SE ES NO FI HU DK IE EL AT PT IS CZ EE CY SL PL MT LV LU SK LT Country Total of members and alternates

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 31

Concept papers / Guidelines developed by the CHMP in 2 0 0 7

= > Do not delegate national expert( s) to EMA w ithout clear objectives

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 32

Lietuvos Centrinių vaistų registracijų evoliucija

1991 2004 2006/7 2010/11

1 Lithuanian CRP (Advagraf) Start of EC & CHMP First constant annual European Contracts and incomes Foreseen constant European Contracts and incomes

  • f 2-5 CRP maintenance

CADREAC & PERF Lithuanian Pharmoclogy Committee First competitive European Contracts and incomes

1997

2 Lithuanian CRP (Modigraf) Confirmed 6th and 7th Lithuanian CRP (Renal area, 2nd Rap) Started 5th Lithuania CRP (Antiemetic – 1st Rap) Current 3 ir 4 Lithuanian CRP (Transplantation and Renal area)

Agency in EU Fram ew ork

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 33

… just m anage the risks to keep experts m otivated

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 34

1 0 . Arrange consultations w ithin a EU regulatory fram ew ork

Thus, You are welcome to meet the experts of The State Medicines Control Agency GintautasBarcys@vvkt.lt RomaldasMaciulaitis@vvkt.lt

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 35

Conclusions

  • Phasing-in to EU regulatory system harmonize

the principles of evaluations and activities

  • Safety evaluation remains one of key national

duties

  • Invest into local competences and explore EU

com m itm ents and opportunities

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 36

Special thanks to:

  • Dr Sif Ormarsdóttir, Islandic MCA, CHMP London
  • Dr Truus (G.M.) Janse-de Hoog, Chair CMD (h), London
  • Dr Daniel Brasseur, Former Chair of CHMP, London
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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 37

Croatia, let’s contribute to the developm ent

  • f EU regulatory com petence

Thank you