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

Reputed Client of China



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The European regulatory system for medicines: Overview of drug approval

04 Dec 2018

The European regulatory system is formed by combining 50 regulatory authorities from 31 different European Economic Area (EEA) countries (28 EU Member States plus Iceland, Liechtenstein and Norway) along with the European Commission and EMA.

Legal basis for the Marketing Authorization Application (MAA)in the European Union (EU) is explained by the Directive 2001/83/EC. EudraLex is the collection of rules and regulations governing medicinal products in the European Union for human and veterinary use. Marketing authorisation for the medicinal products is given on the basis of Directive 2001/83/EC as below articles:

  • Article 8(3) for full dossier for new drug also termed as Full Mixed Dossier
  • Article 10(1) and 10(2) for bioequivalent generics
  • Article 10(3) applications for generics which differs from originators products also termed as Hybrid Dossier
  • Article 10a for bibliographical applications which are well established
  • Article 10b for fixed combinations
  • Article 10c for informed consent application dossiers

Legal basis and relevant guidelines for biosimilars:

Biosimilars are biological medicinal products containing same active ingredient like reference biologic, which is already approved by the regulatory agencies. Biosimilars have similar biological activity as well as safety and efficacy profiles like the reference biologics.

The legal bases for the biosimilars’ applications are mentioned in the Article 6 of Regulation (EC) No 726/2004 and Article 10(4) of Directive 2001/83/EC, as amended. Requirements for the submission is mentioned in Part II, Section 4, Annex I of Directive 2001/83/EC, as amended. In addition, the following guidelines should be taken into account:


  • Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance – quality issues (EMA/CHMP/BWP/247713/2012)
  • Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/ EMEA/CHMP/BMWP/42832/2005)

European Marketing Authorizations

Marketing approval in the Europe is provided on the basis of 3 procedures: 

Centralized procedure allows marketing of the drug throughout the EU on the basis of a single assessment. This application is submitted to European Medicines Agency (EMA).

Decentralized procedure provides the marketing authorization of a product in one or more members of the EU if it does not fall under any centralized procedure; application is submitted to the council of a particular area.

Mutual-recognition procedure is that wherein a company has MAA in one EU Member States and can apply for the authorization in other Member States of EU.

Source: EMA guidlinces

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