March 2014

January 2014

EMA >> Committees >> CHMP>> Agendas, minutes and highlights

May 2014

June 2014

July 2014

2013

LEMTRADA Alentuzumab (anti-CD52) Relapsing remitting MS

REMSIMA

INFLECTRAInfliximab (anti-TNF) Same indications as Remicade

KADCYLA Trastuzumab emtansine HER2-positive breast cancer

2014

SYLVANT Siltuximab (anti-IL-6) Multicentric Castleman’s disease

ENTYVIO Vedolizumab (anti-integrin α4β7)Moderately to severely active Crohn’s disease

GAZYVARO Obinutuzumab (anti-CD20) Chronic lymphocytic leukaemia

7

9

30/07/2014

14

• Manufacture, characterisation and control of the DS• Specifications• Comparability / biosimilarity• Plasma-derived medicinal products• Plasma master file• Vaccines• Stability

• Pharmaceutical Development

• Product Information

• Adventitious Agents / Viral Safety

• Transmissible Spongiform Encephalopathies (TSE)

• CJD related

• Investigational Medicinal Products

• GMO

Concept paper on review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement,

reduction and refinement) in regulatory testing of medicinal products (EMA/CHMP/CVMP/JEG-3Rs/704685/2012)

(draft for consultation until 31 May 2014)

Technical update of EMA Biological guidelines to implement best practice with regard to 3Rs:

1. Production and quality control of monoclonal antibodies and related substances

2. Potency testing of cell based immunotherapy medicinal products for the treatment of cancer

3. Production and quality control of animal immunoglobins and immunosera for human use

4. Pharmaceutical and biological aspects of combined vaccines

5. Production and quality control of cytokine products derived by biotechnological process

• EMA-FDA Pilot for QbD – Progress to Date

• Normal Operating Ranges, Proven Acceptable Ranges and Design Space (PAT Team)

• Workshop on characterisation of new clotting factor concentrates (FVIII, FIX) with respect to potency assays used for

labelling and testing of post infusion samples (held 28-29 November 2013)

• CHMP discussion on the assessment of orphan similarity. Draft template for BWP report on similarity concerning the

molecular structure