It is very nice to visit Lambda facility and thanks to warm welcome provided by all the teams. I can easily say one of the best CRO I ever visited. People here are wonderful and doing great job

Reputed Client of Israel

Awesome hospitality & fantastic office. All the best!

Reputed Client of Japan

Excellent hospitality and cooperation received throughout the audit. People are knowledgeable and extremely transparent. Looking for long time relation

Reputed Client of Asia

Facility is too good to conduct the BABE studies and adherence to protocol and quality assurance in conducting studies are meeting sponsor expectations and requirements.

Reputed Client of India

Facility is good, people r trained well and know the subject on which they r working. All the best.

Reputed Client of USA

Highly innovative and advanced research centre that possess bright future for the development of the country.

Reputed International Government Body

It is one of the best facility in India for BA/BE

Reputed Regulatory Authority

Lambda is a very professional CRO. All the staff here are experienced and very knowledgeable. I'm grateful for their accommodations and hospitality. The future, if we want to carry out BE study, we will ask Lambda help again.

Reputed Client of Europe

It was a really pleasant meeting with the PV department, and I am looking forward to the next visit.

Reputed Client of Europe

Amazing and best CRO I ever seen

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Home / Blog

EMA unveils the new features to enhance the PRIority MEdicines scheme

18 Apr 2023

  • To improve its PRIority MEdicines (PRIME) programme, which aims to hasten the development of medicines for unmet needs, the European Medicines Agency (EMA) has taken recommendations from a recent report. The modifications include making sure that drug sponsors and regulators agree on the process and deadlines for getting the medicine through review.
  • To give businesses creating medications for unmet medical needs more opportunity to interact with regulators, EMA introduced the pathway in 2016. The roadmap and tracker will take the role of the PRIME yearly update beginning in March 2023 as a pilot programme for any items that have not previously been covered in a Kick-off meeting.
  • The regulatory roadmap and development tracker, which contains details on anticipated regulatory filings and contacts with regulators, must be kept up to date and maintained by applicants as per EMA requirements
  • The revised guidance now permits submission preparedness meetings, which will be set up about a year before the applicant files their application for a marketing authorisation.
  • Potential applicants would also be required to provide developed strategies for the generation of post-marketing proof, where appropriate.
  • To arrange a submission readiness meeting with the PRIME Rapporteur and the assessment team, pertinent national experts, and the EMA product team, applicants are urged to get in touch with their PRIME scientific coordinator about 15 months prior to when they anticipate submitting their applications. The framework of the meeting will be the same as the kick-off meeting, but candidates will have an earlier opportunity to discuss what needs to be done before they submit their applications.
  • The guidance indicates that in this situation, applicants should consider that, to the extent feasible, the [submission] package should include all necessary data needed to support the intended [marketing application authorization (MAA)]. This should take into account the possibility that applications for conditional marketing authorizations or marketing authorizations under unusual circumstances may not require as much evidence. At this time, applicants would also be required to demonstrate developed strategies for the creation of post-marketing evidence, as appropriate.

Decision Tree :

PRIME: area of unmet medical need :


  • Multiple myeloma
  • Diffuse large B-cell lymphoma
  • B-cell acute lymphoblastic leukaemia
  • Mantel cell lymphoma
  • Locally advanced or metastatic solid tumour
  • Primary mediastinal large B-cell lymphoma
  • Metastatic synovial sarcoma
  • Glioblastoma
  • Rituximab refractory post-transplant lymphoproliferative disorder
  • Hodgkin lymphoma
  • Myelodysplastic syndromes
  • Sezary syndrome
  • Urgent allogeneic haematopoietic stem cell transplantations

Endocrinology/Gynaecology / Fertility / Metabolism

  • Acute hepatic porphyria
  • Obesity and control hunger caused by genetics
  • Primary hyperoxaluria type 1
  • Mucopolysaccharidosis
  • Acid sphingomyelinase deficiency
  • X-linked myotubular myopathy
  • Thymidine kinase 2 deficiency
  • Type 1 diabetes
  • C3 glomerulopathy

Haematology / Hemostaseology

  • Transfusion-dependant B-thalassemia
  • Haemophilia B
  • Sickle cell disease
  • Epstein-Bar Virus-associated Post Transplant Lymphoproliferative Disorder
  • Haemophilia A
  • Paroxysmal nocturnal haemoglobinuria
  • Fanconi anaemia Type A
  • Myelofibrosis


  • Spinal muscular atrophy
  • Early cerebral adrenoleukodystrophy
  • Huntington's disease
  • Variant late infantile neuronal ceroid lipofuscinosis 6
  • Friedreich's ataxia


  • Ebola
  • Chikungunya
  • Tuberculosis
  • Zika virus
  • Lower respiratory tract disease (LRTD) caused by RSV

Infectious diseases

  • Hepatitis D virus infection
  • Septic shock
  • Respiratory syncytial virus
  • BK virus, cytomegalovirus, human herpes virus-6, Epstein Barr virus, and/or adenovirus in allogeneic HSCT recipients

Immunology / Rheumatology / Transplantation

  • Prevention of graft rejection following solid organ transplantation
  • X-linked severe combined immunodeficiency
  • Dermatomyositis
  • Leukocyte Adhesion Deficiency-I


  • X-linked Retinitis Pigmentosa owing to defects in Retinitis Pigmentosa GTPase Regulator
  • Achromatopsia associated with defects in CNGB3
  • Leber's congenital amaurosis due to the p.Cys998X mutation in the CEP290 Gene

Gastroenterology / Hepatology

  • Progressive familial intrahepatic cholestasis
  • Non-alcoholic steatohepatitis
  • Primary biliary cholangitis

Cardiovascular Diseases

  • Reversal of antiplatelet effects of ticagrelor in patients with uncontrolled major or life-threatening bleeding or requiring urgent surgery or invasive procedure
  • Pulmonary arterial hypertension


  • Dystrophic Epidermolysis Bullosa
  • X-linked hypohidrotic ectodermal dysplasia

Pneumology / Allergology

  • Non-cystic fibrosis bronchiectasis


  • Postpartum depression


  • Osteogenesis imperfecta types I, III and IV


Outcome of PRIME eligibility requests per therapeutic area

Orphan designation: Outcome of PRIME eligibility requests for orphan and non-orphan medical products


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