Press release - Parliament adopts its position on EU pharmaceutical reform
Retrieved on:
Thursday, April 18, 2024
Key Points:
Patient
Why the government’s haste in changing the health system could come back to haunt it
Retrieved on:
Thursday, April 18, 2024
However, in the health sector this need for speed entails policy risks that could come back to bite the government before the next election.
Key Points:
- However, in the health sector this need for speed entails policy risks that could come back to bite the government before the next election.
- The biggest such risk comes from the disestablishment of the Māori Health Authority-Te Aka Whai Ora.
More health sector confusion
- While the parts of the act referring to the Māori Health Authority have been excised, the act retains its primary focus on reducing health inequities.
- To date, health minister Shane Reti has avoided using the words “equity” or “inequities”, instead preferring a generic focus on improving health outcomes, including for Māori.
- But the planning and decision making mandated under the legislation still require government health agencies to address health inequities.
- Despite having misgivings about the re-centralisation of the health system, the government has not reversed the merging of 20 District Health Boards into Health New Zealand.
Health targets rebooted
- Other changes resemble initiatives introduced during the last National-led government in 2009, including specific health targets.
- The health targets involve specified performance levels, such as ensuring that 95% of patients visiting emergency departments are seen within six hours.
- Health New Zealand bears either the cost of continuing to fund security guards or the reputational risk of their reduced presence.
- The government may have already dented minister Reti’s chances of building positive relationships with health sector leaders and interest groups.
- The Māori Health Authority had widespread support from health sector groups.
- While governments often draw criticism from the health sector, few have done so quite this rapidly.
Tim Tenbensel receives funding from the Health Research Council. He is affiliated with Health Coalition Aotearoa.
Herbal medicinal product: Eucalypti aetheroleumArray,Array,Array, F: Assessment finalised
Retrieved on:
Thursday, April 18, 2024
Herbal medicinal product: Eucalypti aetheroleumArray,Array,Array, F: Assessment finalised
Key Points:
Herbal medicinal product: Eucalypti aetheroleumArray,Array,Array, F: Assessment finalised
Herbal medicinal product: Pilosellae herba cum radiceArray, F: Assessment finalised
Retrieved on:
Thursday, April 18, 2024
Overview
Key Points:
- Overview
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of mouse-ear hawkweed. - The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing mouse-ear hawkweed.
- Herbal medicines containing mouse-ear hawkweed are usually available as a herbal tea to be drunk and in solid forms to be taken by mouth.
- Key facts
- Latin name
- Pilosellae herba cum radice
- English common name
- Mouse-ear hawkweed
- Botanical name
Hieracium pilosella L.
- Therapeutic area
- Urinary tract and genital disorders
- Status
- F: Assessment finalised
- Date added to the inventory
- Date added to priority list
- Outcome of European assessment
- European Union herbal monograph
Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)
Retrieved on:
Thursday, April 18, 2024
Reproduction, Particle size, Q&A, Patient, Lung, Chronic obstructive pulmonary disease, DPI, Pharmacokinetics, Child, Isocyanate, International Council, Scope, Abbreviation, Asthma, OIP, European, COPD, APSD, Absorption, Rheumatology, Risk, Draft, EMA, Safety, TE, CHMP, MDI, Pharmacodynamics, IVIVC, Documentation, Taste, Comparison, Inhalation, Charcoal, Clinical Trials Directive, The central science, Drug development, Literature, ICH, Guideline, Gastrointestinal tract, GI, Marketing, Medication package insert, Excipient, Quality, QWP, Medical device
21
Key Points:
- 21
Guideline on the requirements for demonstrating
therapeutic equivalence between orally inhaled products
(OIP) for asthma and chronic obstructive pulmonary
disease (COPD)22
Table of contents
23
Executive summary ..................................................................................... 4
24
1.
- Primary PK parameters to be analysed and acceptance criteria .............................. 14
43
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/202451
6.4.
- Definitions ........................................................................................... 18
56
List of Abbreviations.................................................................................. 20
57
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/202458
Executive summary
59
This guideline is the 2nd revision of the CHMP Guideline formerly called ?Guideline on the requirements
60
for clinical documentation for orally inhaled products (OIP) including the requirements for
61
demonstration of therapeutic equivalence between two inhaled products for use in the treatment of
62
asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of
63
asthma in children and adolescents?.
- It addresses the requirements for demonstration of therapeutic
64
equivalence (TE) between orally inhaled products containing the same active moiety(ies).
- It is generally not recommended to aim at demonstrating TE using pharmacodynamic
70
or clinical endpoints as these are deemed insensitive.
- This
83
guideline is directed particularly at the requirements for demonstrating TE between OIPs containing the
84
same active moiety(ies) and used in the management and treatment of patients with asthma and/or
85
COPD.
- 86
The guideline was first published as points to consider in 2004 and revised for the first time and
87
became guideline in 2009.
- Since then, a number of Q&A documents have been published by Quality
88
Working Party (QWP) and former Pharmacokinetic Working Party (PKWP).
- Scope
93
This document provides guidance on the requirements for demonstrating TE between OIPs, including
94
both, single active substance products and combination products.
- Also, in the case that there is a need
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/202498
to confirm similarity to a product for which literature data is available (e.g., well-established use
99
applications), the same principles apply.
- Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024132
4.
- Products for nebulisation
177
This guideline applies also for products for nebulisation although it is acknowledged that the
178
performance of these is highly dependent on the nebuliser used.
- In vitro criteria for demonstrating TE
206
The test and reference products should be compared in order to conclude on TE.
- Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024211
2122.
- Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024353
6.2.
- Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024392
6.3.
- If the
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024432
different strengths of the test and the reference product are not shown to be proportional in vitro, in
433
vivo equivalence should be demonstrated with a bracketing approach.
- Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024471
6.4.
- Griffin, 1964
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024553
which both reference product-na?ve and experienced users should be included.
- 568
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024569
10.
- Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024Product strength
Product strength may be either the delivered
dose or the metered dose. - 570
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024571
List of Abbreviations
APSDAerodynamic Particle Size Distribution
AUC
Area Under the Curve
CHMP
Committee for Medicinal Products for Human
UseCI
Confidence Interval
Cmax
Peak concentration
COPD
Chronic Obstructive Pulmonary Disease
DPI
Dry Powder Inhaler
FPD
Fine Particle Dose
GI
Gastrointestinal
ICH
International Conference on Harmonisation
IVIVC
In vitro in vivo correlation
MDI
Metered Dose Inhaler
OIP
Orally Inhaled Product
PD
Pharmacodynamic
PK
Pharmacokinetic
pMDI
Pressurised Metered Dose Inhaler
QWP
Quality Working Party
SmPC
Summary of Product Characteristics
TE
Therapeutic equivalence
tmax
Time to peak concentration
572
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024
Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal products
Retrieved on:
Thursday, April 18, 2024
Reproduction, Midol, Medical device, Particle size, QRD, Patient, Chronic obstructive pulmonary disease, Food packaging, DPI, CTD, Isocyanate, European Pharmacopoeia, Roflumilast, GSD, Scope, Asthma, OIP, Clinical trial, European, COPD, APSD, Marketing, CQA, Nasal mucosa, Medical device regulation, Medication, Solvent, No-no, RH, Ageing, Draft, Gel, EMA, Freezing, Outline, Risk assessment, Uniformity, Chemistry, Pressurization, Micronization, Clutch (eggs), Blister, CHMP, Mass, MDI, Solubility, Documentation, Life cycle, Pharmacopoeia, Capsule, Bias, LDPE, Inhalation, Conformity, Publication, The central science, ICH, Orientation, NB, Lubricant, AIM, Excipient, Temperature, Monograph, Humidity, Cold, Light, Life, Medication package insert, Rugosity, Quality, Water, Yesa, Administration, Weight loss, Life insurance
17
Key Points:
- 17
Guideline on the pharmaceutical quality of inhalation and
nasal medicinal products18
Table of contents
19
Executive summary ..................................................................................... 3
20
1.
- Lifecycle management ........................................................................................ 28
49
Definitions ................................................................................................. 29
16
50
51Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024Page 2/30
52
Executive summary
53
This guideline is the first revision of the guideline on pharmaceutical quality of inhalation and nasal
54
products (EMEA/CHMP/QWP/49313/2005 Corr).
- Quality aspects specific to inhalation and nasal medicinal products are discussed, the need for
66
safety testing (e.g., for excipients and leachables) is also considered.
- 69
Detailed guidance on pharmaceutical development study designs (e.g., priming studies) and the
70
analytical procedures primarily used for inhalation and nasal medicinal products (e.g., cascade
71
impactor analysis) is not included in this guideline.
- Scope
74
The guideline addresses requirements "on the quality of inhalation and nasal medicinal products" in
75
new marketing authorisation applications, including abridged applications.
- Liquid inhalation anaesthetics and nasal ointments, creams and gels are
88
excluded, however the general principles described in this guideline should be considered.
- 118
Different polymorphic forms including any amorphous content could affect the quality or performance
119
of the finished medicinal product.
- Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024Page 4/30
132
The primary packaging, type of inhaler and, if necessary, the secondary packaging or other
133
components required for reasons of stability should be described.
- Pharmaceutical
development study(a) Physical
characterisation
(b) Minimum fill
justification
(c) Extractable
volumePressurised
Dry powder
Preparations for
Non-
metered-
inhalers (DPI)
nebulisation
pressurised
dose
metered-
Device-
Pre-
Single-
Multi-
(pMDI)
metered
metered
dose
dose
inhalers
Yesa
Yes
Yes
Yesa
Yesa
Yesa
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
Yes
No
No
inhalers
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024dose
Page 5/30
Table 4.2.1.
- The last doses delivered by
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024Page 7/30
179
the inhaler as defined by the label claim, should meet the finished medicinal product specification limits
180
for delivered dose and fine particle dose.
- Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024Page 9/30
263
2644.2.2.8.
- Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024Page 11/30
345
Instructions regarding cold temperature use should be provided in the product information.
- Finished medicinal
productPressurised
Dry powder inhalers
Preparations for
metered-
(DPI)
nebulisation
dose
Nonpressurised
metered-doseDevice-
Pre-
Single-
Multi-
(pMDI)
metered
metered
dose
dose
inhalers
(a) Description
Yes
Yes
Yes
Yes
Yes
Yes
(b) Assay
Yes
Yes
Yes
Yes
Yes
Yes
(c) Moisture content
Yes
Yes
Yes
No
No
No
Yes
Yes
Yes
No
No
Yes
Yes
Yes
Yes
No
No
Yes
specification test
(d) Mean delivered
dose
(e) Uniformity of
delivered doseinhalers
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024Page 15/30
Table 4.2.2.
- Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024Page 16/30
510
4.2.5.4.
- The proposed specification limits should take into account the shelf-life performance of the
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024Page 17/30
552
medicinal product.
- Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024Page 18/30
586
All medical devices, including inhalers and nasal devices, have to fulfil the general requirements as
587
outlined in the Medical Device Regulation (EU) 2017/745.
- Stability (CTD 3.2.P.8)
598
All inhalation medicinal products should be tested on stability against the stability indicating tests
599
included in the finished medicinal product specification.
- Quality data requirements as
619
described in this guideline should be met, supplemented by appropriate comparative quality and
620
clinical data with respect to the chosen reference medicinal product.
- 621
For inhalation medicinal products comparative in vitro data between the abridged application medicinal
622
product and the reference medicinal product must be provided.
- Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024Page 20/30
670
Nature and contents of container: The type of the device and its components should be listed.
- Nasal medicinal products
695
Inhalation and nasal medicinal products have many similarities and therefore, most of the
696
requirements specified for inhalation medicinal products in section 4 also apply for nasal medicinal
697
products.
- One difference between inhalation and nasal medicinal products is the desired
698
particle/droplet size of the finished medicinal product.
- Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024Page 21/30
704
5.2.
- Nasal liquids
Pharmaceutical
development
studyPressurised
Nasal
metered-
powders,
dose nasal
device-
spray
metered
NonSingledose
dropsMultidose
dropsSingle-
pressurised
dose
multidose
spray
metereddose spray
(a) Physical
characterisation
(b) Minimum fill
justification
(d) Extractables /
leachablesYesa
Yes
Yesa
Yesa
Yesa
Yesa
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
Yes
No
No
Yes
Yes
Yes
Yes
No
No
No
Yes
Yes
Yes
No
No
Yes
Yes
(f) Particle /
droplet size
distribution
(g) Uniformity of
delivered dose
through container
life
(j) Actuator /
mouthpiece
depositionGuideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024Page 22/30
Table 5.2.1.
- Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024Page 23/30
728
5.2.2.2.
- Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024Page 24/30
769
5.2.5.
- Quality data requirements as described in
799
this guideline should be met, supplemented by appropriate comparative quality and clinical data with
800
respect to the chosen reference medicinal product.
- Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024Page 27/30
849
5.5.
- 866
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024Page 28/30
867
Definitions
Activation:The act of setting in motion the delivery device.
- Delivery device:
The sum of component(s) of the container closure system responsible for
delivering the active substance to the respiratory tract (inhalation medicinal
product) or the nasal and/or pharyngeal region (nasal medicinal product). - Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024Page 29/30
Label claim:
The amount of active substance (usually on a per actuation basis) declared
on the label of the medicinal product. - Nasal medicinal
A finished medicinal product (including the delivery device, where
product:
applicable) whose intended site of deposition is the nasal and/or pharyngeal
region. - 868
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024Page 30/30
Orphan designation: (6aR,10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydrocannabinol-9-carboxylic acid- Treatment of cystic fibrosis, 14/10/2016 Withdrawn
Retrieved on:
Thursday, April 18, 2024
Eurostat, Diagnosis, Civil service commission, Absorption, Lower respiratory tract infection, Exercise, Cell, Infection, DSM-IV codes, Inflammation, Patient, Committee, Cystic fibrosis, Knowledge, Digestion, Regulation, Bacteria, Food, EMA, IRIS, Anti-inflammatory, Mucus, CB2, European, COMP, Pancreas, Sponsor, Ivacaftor, European Commission, Safety, CFTR, Marketing, Medicine, Pharmaceutical industry
Orphan designation: (6aR,10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydrocannabinol-9-carboxylic acid- Treatment of cystic fibrosis, 14/10/2016 Withdrawn
Key Points:
Orphan designation: (6aR,10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydrocannabinol-9-carboxylic acid- Treatment of cystic fibrosis, 14/10/2016 Withdrawn
Orphan designation: mRNA encoding the human CFTR gene Treatment of cystic fibrosis, 19/02/2024 Positive
Retrieved on:
Thursday, April 18, 2024
Overview
Key Points:
- Overview
This medicine was designated as an orphan medicine for the treatment of cystic fibrosis in the European Union on 19 February 2024. - Orphan designation does not mean the medicine is available or authorised for use.
- All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
- EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
Orphan designation: (4R)-3-(4-fluoro-2-hydroxyphenyl)-4-methyl-4,5-dihydro-1H-pyrazole-1-carboximidamide hydrochloride Treatment of systemic sclerosis, 12/01/2024 Positive
Retrieved on:
Thursday, April 18, 2024
Overview
Key Points:
- Overview
This medicine was designated as an orphan medicine for the treatment of systemic sclerosis on 12 January 2024. - Orphan designation does not mean the medicine is available or authorised for use.
- All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
- EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
Orphan designation: golcadomide hydrochloride Treatment of diffuse large B-cell lymphoma, 12/01/2024 Positive
Retrieved on:
Thursday, April 18, 2024
Overview
Key Points:
- Overview
This medicine was designated as an orphan medicine for the treatment of diffuse large B-cell lymphoma on 12 January 2024. - Orphan designation does not mean the medicine is available or authorised for use.
- All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
- EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: