The powers of national regulatory authorities as agents of EU law
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DOI: 10.1007/s12027-017-0487-y
Abstract: Over the past few decades, National Regulatory Authorities have acquired a central role in the implementation of EU law. NRAs are established by the Member States, implying that they are part of the national administrative… read more here.
Keywords: agents law; law; powers national; national regulatory ... See more keywords
Worldwide perspective of biosimilars for psoriasis
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DOI: 10.1111/bjd.16027
Abstract: This issue of the BJD includes an important paper from the International Psoriasis Council Biosimilars Working Group, which gives a global perspective on the regulatory issues regarding biosimilar use for psoriasis and psoriatic arthritis in… read more here.
Keywords: worldwide perspective; tnf inhibitors; psoriasis; arthritis ... See more keywords
INVOLVEMENT OF STAKEHOLDERS IN THE REPORTING PROCESS OF SERIOUS ADVERSE EVENTS DURING CLINICAL TRIALS IN A SUB-SAHARAN RESEARCH CENTER, LAMBARÉNÉ, GABON
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DOI: 10.1136/bmjgh-2016-000260.169
Abstract: Background The pharmacovigilance of medical products for human use should start during the clinical development and continues after licensure. In developed countries, regulatory agencies are actively involved in all steps of pharmacovigilance. In sub-Saharan African… read more here.
Keywords: involvement stakeholders; serious adverse; sub saharan; clinical trials ... See more keywords
Regulatory requirements for the registration of generic medicines and format of drug dossiers: procedures in Sri Lanka in comparison with selected regulatory authorities
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DOI: 10.1186/s40545-018-0141-2
Abstract: BackgroundThe regulatory requirements for approval of generic medicines and the format of compiling drug dossiers vary among regulatory authorities. The variation is particularly wide between High-income countries (HIC) and lower and middle-income countries (LMIC) with… read more here.
Keywords: sri lanka; drug; drug dossiers; generic medicines ... See more keywords