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Submission Type

Type of regulatory submission / activity (e.g. initial, variation, renewal). Regionally defined.

eCTD 4.0 Submission Type 97 terms
All agencies EMA FDA SwissMedic
Term Code Agency Status
Initial Marketing Authorisation Application 100000155689 EMA Active
Variation Type IA 100000155690 EMA Active
Variation Type IAIN 100000155691 EMA Active
Variation Type IB 100000155692 EMA Active
Variation Type II 100000155693 EMA Active
National Variation 100000155694 EMA Active
Line Extension 100000155695 EMA Active
Periodic Safety Update Report 100000155696 EMA Active
Renewal 100000155697 EMA Active
Specific Obligation 100000155699 EMA Active
Active Substance Master File 100000155700 EMA Active
Plasma Master File 100000155701 EMA Active
Annual Reassessment 100000155703 EMA Active
Urgent Safety Restriction 100000155704 EMA Active
Paediatric Submission acc. Article 29 100000155705 EMA Active
Paediatric Submission acc. Article 46 100000155706 EMA Active
WHO Cooperation acc. Article 58 100000155707 EMA Active
Notification acc. Article 61(3) 100000155708 EMA Active
Transfer of a marketing authorisation 100000155709 EMA Active
Lifting of a Suspension 100000155710 EMA Active
Withdrawal 100000155711 EMA Active
Risk Management Plan 100000155713 EMA Active
Post-Authorisation Measure 100000155717 EMA Active
Periodic Safety Update Single Assessment 100000155718 EMA Active
New Active Substance 100001 SwissMedic —
Known Active Substance 100002 SwissMedic —
Co-Marketing Medicinal Product 100003 SwissMedic —
Parallel Import 100004 SwissMedic —
Type IA Variation 100005 SwissMedic —
Type IA Variation for immediate notification 100006 SwissMedic —
Type IB Variation 100007 SwissMedic —
Type II Variation 100008 SwissMedic —
Extension 100009 SwissMedic —
Prolongation, renouncement of prolongation of Marketing Authorisation, notification of no marketing or interruption to distribution 100010 SwissMedic —
Follow-up Measure 100011 SwissMedic —
Periodic Safety Update Report 100012 SwissMedic —
Withdrawal 100013 SwissMedic —
Transfer of Marketing Authorisation, Change of name of applicant, change of address of applicant 100014 SwissMedic —
Drug Master File 100015 SwissMedic —
Plasma Master File 100016 SwissMedic —
Application for recognition of orphan drug status or fast track status 100017 SwissMedic —
Advice 100018 SwissMedic —
No regulatory activity 100019 SwissMedic —
Certificate of suitability application to EDQM 200000002290 EMA Active
Clinical data for publication – Final Version 200000002291 EMA Active
Clinical data for publication – Redacted Proposal 200000002292 EMA Active
Paediatric investigational plan according to article 7, 8 or 30 of the Reg (EC) 1901/2006 200000002293 EMA Active
Annex II condition related to a post-authorisation measure 200000002299 EMA Active
Corrective Action/Preventive Action related to a post-authorisation measure 200000002300 EMA Active
Legally binding measure related to a post-authorisation measure 200000002301 EMA Active
Additional pharmacovigilance activity in the risk-management plan 200000002302 EMA Active
Submission of a post-authorisation efficacy study 200000002303 EMA Active
Recommendation related to a post-authorisation measure 200000002305 EMA Active
Submission of a post-authorisation safety study protocol (according article 107n Dir. 2001/83/EC). 200000002308 EMA Active
Submission of a post-authorisation safety study report (according to article 107q Dir. 2001/83/EC). 200000002310 EMA Active
Referral under Article 107i Dir. 2001/83/EC 200000002311 EMA Active
Referral under Article 16c (1c) Dir. 2001/83/EC 200000002312 EMA Active
Referral under Article 16c(4) Dir. 2001/83/EC 200000002313 EMA Active
Referral under Article 20 Reg (EC) 726/2004 200000002314 EMA Active
Referral under Article 29(4) Dir. 2001/83/EC 200000002315 EMA Active
Referral under Article 29 paediatric Reg (EC) 1901/2006 200000002318 EMA Active
Referral under Article 30 Dir. 2001/83/EC 200000002319 EMA Active
Referral under Article 31 Dir. 2001/83/EC 200000002320 EMA Active
Referral under Article 35 Dir. 2001/83/EC 200000002321 EMA Active
Referral under Article 5(3) Reg (EC) 726/2004 200000002322 EMA Active
Repeat Use Procedure 200000002323 EMA Active
no regulatory activity 200000002325 EMA Active
Paediatric Submission acc. Article 46 200000043524 EMA Active
Article 18 220000000042 EMA Active
ActStatusActive active FDA —
New Drug Application (NDA) us_application_type_1 FDA —
Premarket Notification 510k (510K) us_application_type_10 FDA —
Abbreviated New Drug Application (ANDA) us_application_type_2 FDA —
Biologic License Application (BLA) us_application_type_3 FDA —
Investigational New Drug (IND) us_application_type_4 FDA —
Drug Master File (MF) us_application_type_5 FDA —
Emergency Use Authorization (EUA) us_application_type_6 FDA —
Investigational Device Exemption (IDE) us_application_type_7 FDA —
Premarket Approval Application (PMA) us_application_type_9 FDA —
Original Application us_submission_type_1 FDA —
Periodic Safety Reports us_submission_type_10 FDA —
REMS Supplement us_submission_type_11 FDA —
Efficacy Supplement us_submission_type_2 FDA —
Chemistry Manufacturing Controls Supplement us_submission_type_3 FDA —
Labeling Supplement us_submission_type_4 FDA —
Annual Report us_submission_type_5 FDA —
Product Correspondence us_submission_type_6 FDA —
Postmarketing Requirements or Postmarketing Commitments us_submission_type_7 FDA —
Promotional Labeling Advertising us_submission_type_8 FDA —
IND Safety Reports us_submission_type_9 FDA —
Original us_submission_unit_type_1 FDA —
Presubmission us_submission_unit_type_2 FDA —
Application us_submission_unit_type_3 FDA —
Amendment us_submission_unit_type_4 FDA —
Resubmission us_submission_unit_type_5 FDA —
Report us_submission_unit_type_6 FDA —
Correspondence us_submission_unit_type_7 FDA —

97 terms shown across all authorities. Data sourced from public health authority publications and updated periodically.