“Consolidarea Agenției Medicamentului și Dispozitivelor Medicale
a Republicii Moldova ca agenție de reglementare in domeniul
medicamentelor, dispozitivelor medicale și activității
farmaceutice”
“Strengthening of the Medicines and Medical Devices Agency of the
Republic of Moldova as regulatory agency in the field of medicines,
medical devices and pharmaceutical activity”
April 13, 2017
Anželika Oraitė, RTA
Medicines and Medical Devices Agency
Chisinau
Presentation of the Beneficiary and Partners (I)
Medicines and
Medical Devices
Agency of the
Republic of
Moldova
State Medicines
Control Agency under
the Ministry of Health
of the Republic of
Lithuania
Office for Registration
of Medicinal
Products, Medical
Devices and Biocidal
Products of the
Republic of Poland
Presentation of the Beneficiary and Partners (II)
Policy
Implementation
level
Financial and administrative management
BC Project
Leader
Mr. Dumitru
Saghin
MS Project
Leader
Mr. Gintautas
Barcys
Resident
Twinning Adviser
Ms. Anželika
Oraitė
MS Junior
Project Leader
Dr. Grzegorz
Cessak
Resident Twinning
Adviser
Counterpart Ms.
Corina Iacob
Component 1
Key Expert
Component 2
Key Expert
Component 3
Key Expert
Component 4
Key Expert
Component 5
Key Expert
Ms. Lidia
Retkowska-Mika
Dr. Lina
Laurinavičiūtė
Ms. Aleksandra
Rodatus-Gil
Ms.
Gita Krukienė
Ms. Gražina
Bobelienė
Legal Background
According to the Association Agreement between the European Union and
the Republic of Moldova, parties inter alia agreed:
• “to develop their cooperation in the field of public health, with a view to
raising the level of public health safety and protection of human health as
a precondition for sustainable development and economic growth”
(Article 113);
• “the cooperation shall enable the progressive integration of Moldova into
the European Union's health related networks” (Article 115 (a));
• “Moldova shall carry out approximation of its legislation to the EU acts
and international instruments” (Article 116).
Overall Objective
Full and correct implementation of the EU acquis in the area
of medicinal products and medical devices and preparation
of the Medicines and Medical Devices Agency („MMDA“) for
joining the EU regulatory agencies network as an equal
partner.
Project Components
1
Approximation of the Legal Framework and Strengthening
of MMDA’s Institutional and Organizational Capacities;
2
Strengthening of MMDA’s Regulatory Functioning With Respect
to Medicinal Products;
3
Strengthening of MMDA’s Regulatory Functioning With Respect
to Medical Devices;
4
Improvement of Rational Use of Medicines and Medical Devices;
5
Transition of the MMDA to Full Compliance with the EU
Requirements.
Activities of Component 1
1.1 Approximation of the legal framework
1.2 Training of staff on the EU regulatory framework for medicines and medical devices
1.3 Benchmark of functions of the MMDA with EU competent authorities and services
1.4 Analysis of the decision making procedures
Activities of Component 2
2.1 Development of an SOP for the authorisation of medicinal products including building the
infrastructure for risk benefit assessment and robust and independent decision making.
2.2 Training of MMDA staff responsible for carrying out marketing authorisation procedures
2.3 Development of a risk-based enforcement system of medicines quality rules as well as other
GMP, GDP and GVP
2.4 Strengthening of pharmacovigilance
(PV) by establishing a better functioning PV unit
;
2.5 Strengthening of PV by reaching out to the medical and pharmaceutical community
2.6 Drafting SOP Clinical Trial authorisation procedure
2.7 Strengthening the functioning of the MMDA with respect to clinical trials
2.8 Study visits in respect of Component 2
Activities of Component 3
3.1 Development of a SOP for the supervision of the medical devices market
3.2 Training of MMDA staff in respect of medical devices
3.3 Strengthening of vigilance and strengthening enforcement
3.4 Design of IT infrastructure for implantable medical devices register
3.5 Study visits in respect of Component 3
Schedule
Activities of Component 4
4.1 Expert mission about improving mechanisms to ensure availability and access
4.2 Strengthening of compliance /training inspectors
4.3 Enforcement of legislation about promotion of medical products
4.4 Development communication strategy rational use
4.5 Strengthening of supervision of pharmacies and enforcement of GPP
4.6 Study visit / joint inspections abroad
Activities of Component 5
5.1 Strengthening assessment capacity
5.2 Development of Good Governance Practice
5.3 Developing new tasks for the Quality Control laboratory
5.4 Management of the medical products market during the transition
5.5 Study visit in respect of Component 5
Schedule for 2017 (I)
Nº
ACTIVITY
0.
Months
1
2
3
4
5
6
7
8
9
10 11 12
Activities linked to Results 0: Visibility events
X
0.1.
Installation and Kick-off Conference
0.2.
0.3.
Final Closing Conference
Steering Committee Meetings
X
X
X
Activities linked to Results 1: Approximation of the legal framework and strengthening of MMDA’s institutional and
organisational capacities
X
X
Approximation of the legal framework
1.
1.1.
1.2.
1.3.
1.4.
Training of staff on the EU regulatory framework for medicines
and medical devices
Benchmark of functions of the MMDA with EU competent
authorities and services
Analysis of the decision making procedures
X
X
X
Activities linked to Result 2: Strengthening of MMDA’s regulatory functioning with respect to medicinal products
2.1.
2.2.
2.3.
Development of an SOP for the authorisation of medicinal products
including building the infrastructure for risk benefit assessment
and robust and independent decision making.
Training of MMDA staff responsible for carrying out marketing
authorisation procedures
X
Development of a risk-based enforcement system of medicines
quality rules as well as other GMP, GDP and GVP
X
X
X
X
X
X
Schedule for 2017 (II)
Nº
2.4.
2.8.
3.
ACTIVITY
Months
3.2.
Training of MMDA staff in respect of medical devices
4
5
6
7
8
9
X
10 11 12
X
X
X
X
X
X
Activities linked to Result 4: Improvement of rational use of medicines and medical devices in Moldova
4.1.
Expert mission about
availability and access
4.3.
Enforcement of legislation about promotion of medical products
5.3.
3
Activities linked to Result 3: Strengthening of MMDA’s regulatory functioning with respect to medical devices
Development of a SOP for the supervision of the medical devices
market
5.
2
Strengthening of pharmacovigilance by establishing a better
functioning pharmacovigilance unit
Study visits in respect of Component 2 ( 8 MMDA exp. x 5 days)
(trainings, observed GVP; GMP/GDP inspections )
3.1.
4.
1
improving
mechanisms
to
X
ensure
X
X
Activities linked to Result 5: Transition of MMDA to full compliance with the EU requirements
Developing new tasks for the Quality Control laboratory
X
X
X
Trainings in the BC (2017)
•
•
•
•
•
•
Training of staff on the EU regulatory framework for medicines and medical devices;
Training of MMDA staff responsible for carrying out marketing authorisation procedures;
Development of a risk-based enforcement system of medicines quality rules as well as other GMP,
GDP and GVP;
Strengthening of pharmacovigilance by establishing a better functioning pharmacovigilance unit;
Training of MMDA staff in respect of medical devices;
Enforcement of legislation about promotion of medical products.
Expected results: 2017
- At least 15 staff members of the MMDA are trained on the EU regulatory framework for medicines and medical devices
(Component 1)
- At least 10 staff members of the MMDA are trained on the EU regulatory affairs and assessment of medicinal products
(Component 2)
- At least 5 staff members of the MMDA are trained to use risk management principles in decision making process
regarding outcome of the inspections, Quality System for GMP/GDP inspectorate, to ensure compliance with legal
requirements and prevention of serious non-compliance for protection of public health (Component 2)
- At least 3 MMDA Pharmacovigilance staff are trained on the Pharmacovigilance functions (Component 2)
- At least 8 staff members of the MMDA are trained on function as competent authority (Component 3)
Schedule for 2018 (I)
Nº
1.1
ACTIVITY
Months 13
14
15
16
17
18 19 20 21 22
23 24
Activities linked to Result 1: Approximation of the legal framework and strengthening of the MMDA’s institutional and organisational
capacities
X
Approximation of the legal framework
Activities linked to Result 2: Strengthening of MMDA’s regulatory functioning with respect to medicinal products
2.4
Strengthening of pharmacovigilance
functioning pharmacovigilance unit
by
establishing a
better
2.5
Strengthening of pharmacovigilance by reaching out to the medical
and pharmaceutical community
2.6
Drafting SOP Clinical Trial authorisation procedure
2.7
Strengthening the functioning of the MMDA with respect to clinical
trials
X
X
X
X
X
X
Activities linked to Result 3: Strengthening of MMDA’s regulatory functioning with respect to medical devices
3.1
Development of a SOP for the supervision of the medical devices
market
3.2
Training of MMDA staff in respect of medical devices
X
X
X
X
X
Schedule for 2018 (II)
Nº
ACTIVITY
3.3
Strengthening of vigilance and strengthening enforcement
3.5
Study visits in respect of component 3
Months 13
14
15
X
X
16
17
18 19 20 21 22
23 24
X
X
X
Activities linked to Result 4: Improvement of rational use of medicines and medical devices in Moldova
4.2
Strengthening of compliance /training inspectors
4.5
Strengthening of supervision of pharmacies and enforcement of GPP
4.6
Study visit / joint inspections abroad
X
X
X
X
X
X
X
Activities linked to Result 5: Transition of MMDA to full compliance with the EU requirements
5.1
Strengthening assessment capacity
5.2
Development of Good Governance Practice
5.4
Management of the medical products market during the transition
5.5
Study visits /in respect of Component 5
X
X
X
X
X
X
X
X
Trainings in the BC (2018)
• Improving pharmacovigilance by reaching out to the medical and
pharmaceutical community;
• Strengthening of Compliance / Training of GMP, GDP and GCP inspectors;
• Strengthening of supervision of pharmacies and enforcement of GPP;
• Strengthening assessment capacity.
Expected results:
- At least 4 persons are trained for separate groups (e.g. the MMDA staff, health care providers,
patient representatives - on demand) in ADR reporting system for human medicines
(Component 2).
- At least 4 GMP, GDP and GCP inspectors of the MMDA are trained to the level of EU standards
(Component 4)
- Training of GPP inspectors of the MMDA on supervision of pharmacies (Component 4)
- At least 3 MMDA experts trained on preparation of assessment report on the basis of the EMA
guidelines and templates(Component 5)
Study visits 2017-2018
To the Republic of Lithuania
• Study visits in respect of Component 2
• Study visit related to Component 4
• Study visit related to Component 5
To the Republic of Poland
• Study visits in respect of Component 3
• Study visit related to Component 4
• Study visit related to Component 5
Expected results: 2017
1 GVP inspector of the MMDA trained in GVP inspection process following the EU requirements (Component 2)
2 MMDA experts involved in MA procedures trained in marketing authorisation requirements of the EU (Component 2)
2 GMP and 3 GDP inspectors of the MMDA trained in GMP and GDP inspection process following the EU requirements
(Component 2)
Expected results: 2018-2019
3 MMDA staff members trained in best practices in regulation of medical devices (Component 3)
4 GMP/GDP inspectors trained in GMP and GDP inspection process following the EU requirements (Component 4)
2 GCP inspectors trained in GCP inspection process following the EU requirements (Component 4)
2 GPP inspectors trained in GPP inspection process following the national legislation requirements (Component 4)
4 MMDA assessors introduced with the EMA structure of committees and working parties (Component 5)
Duration of the
execution period:
24 months
Number of
Institutions involved:
7
Number of STEs:
47
$
EU-funded
Twinning
Project
Budget:
1.100.000 EUR
Number of
Components:
5
Number of activities:
31
(5 completed activities)
Schedule for future activities
May 2017
MONDAY
Labour Day 1
Free Day 8
15
TUESDAY
WEDNESDAY
2
Victory Day
9
16
THURSDAY
FRIDAY
SATURDAY
SUNDAY
6 Mother’s Day (Lt) 7
3
4
5
10
11
12
13
14
17
18
19
20
21
27
28
3
4
Activity 4.1(I.a. out of II) Expert mission about improving mechanisms to ensure availability and access
(STEs: T. Alonderis, G. Barcys, L. Laurinavičiūtė, )
23
24
25
26
Activity 2.1 (I out of II) Development of an SOP for the authorisation of medicinal products including
building the infrastructure for risk benefit assessment and robust and independent decision making, 3
STE. (Pool of experts: D. Zacharkienė, N. Kalinauskaitė, L. Juonytė-Leonovičienė, V. Liukaitis, V.
Ribokaitė)
Activity 1.1 (II.a. out of IV) Approximation of the legal framework, 4 STE x 20 w/d (in four 5 day
missions) (Gražina Bobelienė, Rima Markuvienė)
Activity 4.1(I.b. out of II) Expert mission about improving mechanisms to ensure availability and access
(G. Krukienė, V. Meldžiukaitė, I. Greičiūtė-Kuprijanov)
29
30
31
1
2
Schedule for future activities
June 2017
MONDAY
TUESDAY
2
3
SUNDAY
Father’s Day 4
5
6
7
8
9
Activity 2.2 Training of the MMDA staff responsible for carrying out marketing authorisation
procedures, 5 STE x 5 w/d Pool of experts: Valdas Liukaitis, Rugilė Pilvinienė, Valdemaras
Brusokas, Audronis Lukošius, Romaldas Mačiulaitis, Marek Surowiec
12
13
14
15
16
Activity 1.1 (IIb. out of IV) Approximation of the legal framework, 4 STE x 20 w/d (in four 5 day
missions) (Katarzyna Postek-Kaczmarczyk, Lidia Retkowska-Mika)
10
11
17
18
29
WEDNESDAY
30
19
THURSDAY
31
FRIDAY
1
SATURDAY
20
21
22
23
St John’s Day 24
27
28
29
30
1
25
2nd Steering
Committee
26
2
Schedule for future activities
July 2017
MONDAY
TUESDAY
26
WEDNESDAY
27
THURSDAY
28
FRIDAY
29
SATURDAY
SUNDAY
30
1
2
3
4
5
6
7
Activity 2.1 (II out of II) Development of an SOP for the authorisation of medicinal products including
building the infrastructure for risk benefit assessment and robust and independent decision making,
3 STE x 10 w/d (in two 5 day missions) Pool pof experts: D. Zacharkienė, N. Kalinauskaitė, L.
Laurinavičiūtė, L. Juonytė-Leonovičienė, V. Liukaitis, V. Ribokaitė
10
11
12
13
14
Activity 2.3 (II out of III) Development of a risk-based enforcement system of medicines quality rules
as well as other GMP, GDP and GVP, 4 STE x 15 w/d (in three 5 day missions) Pool of experts: I.
Vaketaitė, R. Minderytė, R. Dzetaveckienė, M. Gryz, B. Stańczykiewicz, M. Pardecka, K. Szczęsny, D.
Kurnik
17
18
19
20
21
Activity 1.1 (IIIa out of IV) Approximation of the legal framework, 4 STE x 20 w/d (in four 5 day
missions) (STEs: Katarzyna Postek-Kaczmarczyk, Lidia Retkowska-Mika, Gražina Bobelienė, Rima
Markuvienė)
24
25
26
27
28
8
9
15
16
22
23
29
30
Schedule for future activities
August 2017
MONDAY
TUESDAY
31
WEDNESDAY
1
THURSDAY
2
FRIDAY
3
SATURDAY
SUNDAY
4
5
6
11
12
13
18
19
20
25
26 Independence 27
Twinning Summer Holidays
7
8
9
10
Twinning Summer Holidays
14
Assumption Day
15
16
17
Twinning Summer Holidays
21
22
23
24
Twinning Summer Holidays
28
29
30
National Language
31
Twinning Summer Holidays
1
2
3
Schedule for future activities
September 2017
MONDAY
TUESDAY
WEDNESDAY
THURSDAY
FRIDAY
SATURDAY
SUNDAY
28
29
30
31
Free Day (nay) 1
2
3
4
5
6
7
8
9
10
16
17
Activity 4.1 (II out of II) Expert mission about improving mechanisms to ensure availability and access (Gita
Krukienė, Kristina Garuolienė, Tomas Alonderis, Vilma Meldžiukaitė; Gintautas Barcys, Ieva GreičiūtėKuprijanov)
11
12
13
14
15
Activity 2.4 (I out of III) Strengthening of pharmacovigilance by establishing a better functioning
pharmacovigilance unit, 3 STE x 15 w/d (in three 5 day missions) Pool of experts: Andrzej Czesławski; Rita
Dzetaveckienė, Jolanta Gulbinovič; Virginija Žilėnaitė-Puodžiuvienė
18
19
20
21
22
23
24
28
29
30
1
Activity 2.8 Study visits in Lithuania (MAH)
25
26
27
Expected major achievements
1. Legal framework approximated to the EU requirements;
2. MMDA with capacities at the same level as peer institutions
in the EU Member States;
3. Well-trained MMDA officials;
4. Improvement of the rational use of medicines and medical
devices;
5. Safer, better quality and more effective medicinal products
and medical devices to the public.
Let us reach the best results together!
Vă mulțumesc!
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responsabilitatea partenerilor de Twinning și nu reflectă neapărat viziunea Uniunii Europene.
This publication has been produced with the assistance of the European Union. The contents of this
publication are the sole responsibility of the Twinning partners and do not necessarily reflect the views of
the European Union.